Trials (Oulu University Hospital)
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NCTID: NCT04607421
Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2020-12-21 Last Updated: 2023-09-11 Number of Patients: 815 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT04334421
Title: APEMESH- Preventing Perineal Complications After Abdominoperineal Resection Study Summary: Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial. Previous studies on synthetic mesh repair on perineum are almost lacking. Sponsor: Elisa Makarainen-Uhlback Intervention: Composite mesh Start Date: 2020-04-03 Last Updated: 2021-03-23 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Rectal Cancer
NCTID: NCT04597125
Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. Sponsor: Bayer Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) Start Date: 2020-11-09 Last Updated: 2023-11-14 Number of Patients: 696 Recruitment Status: RECRUITING Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
NCTID: NCT01357512
Title: Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer Study Summary: The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation. Sponsor: University of Oulu Intervention: magnetic resonance imaging, Siemens Start Date: 2011-04 Last Updated: 2017-12-02 Number of Patients: 130 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms
NCTID: NCT02950051
Title: Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation Study Summary: The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions. Sponsor: German CLL Study Group Intervention: Fludarabine Start Date: 2016-12-13 Last Updated: 2023-07-06 Number of Patients: 926 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00994812
Title: The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS) Study Summary: The purpose of this study is to determine whether metformin may improve pregnancy rates, and decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational diabetes, in women with polycystic ovary syndrome (PCOS). Sponsor: University of Oulu Intervention: metformin Start Date: 2002-08 Last Updated: 2010-02-23 Number of Patients: 326 Recruitment Status: COMPLETED Condition: Polycystic Ovary Syndrome
NCTID: NCT01675219
Title: Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9) Study Summary: Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs. The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment. Sponsor: Turku University Hospital Intervention: white light TUR-BT Start Date: 2012-12 Last Updated: 2023-04-13 Number of Patients: 400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Bladder Cancer
NCTID: NCT04779125
Title: APEMESH II - Perineal Reconstruction Study Summary: The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting. Sponsor: University of Oulu Intervention: Gluteus plasty enhanced with Progrip self gripping mesh Start Date: 2021-03-19 Last Updated: 2021-05-06 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Rectal Cancer
NCTID: NCT00268892
Title: Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer Study Summary: The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix. Sponsor: Ferring Pharmaceuticals Intervention: Degarelix Start Date: 2006-01 Last Updated: 2010-12-24 Number of Patients: 278 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03267030
Title: Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase Study Summary: Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS). Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities. Sponsor: Birgitte Klug Albertsen Intervention: GRASPA Start Date: 2017-08-23 Last Updated: 2021-01-25 Number of Patients: 55 Recruitment Status: COMPLETED Condition: Acute Lymphoblastic Leukemia
NCTID: NCT04114825
Title: Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer Study Summary: This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V). Sponsor: RhoVac APS Intervention: RV001V Start Date: 2019-11-19 Last Updated: 2021-09-28 Number of Patients: 180 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer Recurrent
NCTID: NCT03650517
Title: Minimally Invasive Right Colectomy Anastomosis Study Study Summary: Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon. A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach. However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best. MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study: 1. Robotic Right Colectomy with ICA 2. Robotic Right Colectomy with ECA 3. Laparoscopic Right Colectomy with ICA 4. Laparoscopic Right Colectomy with ECA All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery. Sponsor: Instituto de Investigación Marqués de Valdecilla Intervention: Extracorporeal Anastomosis Start Date: 2018-11-01 Last Updated: 2019-09-25 Number of Patients: 1200 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]) /computed tomography \[CT\]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants' overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-10-30 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT04680052
Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Study Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-04-15 Last Updated: 2023-08-18 Number of Patients: 654 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT00841152
Title: Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute Study Summary: This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Based on the investigators' previous preclinical research and an ongoing single-center randomized clinical trial on bioactive glass filling, the investigators expect BAG filling to be more efficient compared to TCP in promotion of defect healing and functional recovery after surgery. Sponsor: Turku University Hospital Intervention: Bioactive glass Start Date: 2009-03 Last Updated: 2021-03-16 Number of Patients: 120 Recruitment Status: COMPLETED Condition: Bone Neoplasm
NCTID: NCT04923893
Title: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Study Summary: The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). Sponsor: Janssen Research & Development, LLC Intervention: Bortezomib Start Date: 2021-08-19 Last Updated: 2023-11-09 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT03192020
Title: Trial Comparing Treatment Strategies in Dupuytren's Contracture Study Summary: Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most cost-effective in treating Dupuytren´s contracture. Short- and long-term results will be published. Sponsor: Tampere University Intervention: Percutaneous needle fasciotomy (PNF) Start Date: 2017-09-15 Last Updated: 2023-03-13 Number of Patients: 302 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Dupuytren Contracture
NCTID: NCT04243005
Title: Supramarginal Resection in Glioblastoma Study Summary: Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment. The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is "maximum safe resection of the contrast enhancing tumor", but this may in selected cases be extended to simply "maximum safe resection" tailored to the patient and extent of disease at hand. Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole. Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma. Sponsor: St. Olavs Hospital Intervention: Supramarginal resection Start Date: 2020-07-01 Last Updated: 2022-12-09 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Glioblastoma
NCTID: NCT01918605
Title: Protection of Rectum From High Radiation Doses Using a Spacer Study Summary: The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy. Sponsor: University of Oulu Intervention: Diluted spacer Start Date: 2013-06 Last Updated: 2017-10-27 Number of Patients: 5 Recruitment Status: TERMINATED Condition: Prostatic Neoplasms
NCTID: NCT04464226
Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study. Sponsor: Bayer Intervention: Darolutamide (Nubeqa, BAY1841788) Start Date: 2020-10-20 Last Updated: 2023-11-18 Number of Patients: 678 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT00255606
Title: Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer. Sponsor: Tampere University Intervention: docetaxel Start Date: 2005-08 Last Updated: 2013-06-26 Number of Patients: 360 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03859427
Title: A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Study Summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2019-05-08 Last Updated: 2023-10-27 Number of Patients: 454 Recruitment Status: COMPLETED Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT03206671
Title: Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents Study Summary: The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents. The following primary study questions are going to be analyzed: * the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window. * the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab. Secondary study questions will address * additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates * kinetics of immune reconstitution after treatment * adverse event and severe adverse event profile * inter-individual variability of rituximab response * role of different mechanisms of action of rituximab in advanced B-NHL/B-AL Sponsor: University Hospital Muenster Intervention: Rituximab window Start Date: 2017-08-03 Last Updated: 2021-06-08 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Mature B-cell Non-Hodgkin Lymphoma
NCTID: NCT02064491
Title: Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC Study Summary: The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI. Sponsor: Finnish Lung Cancer Group Intervention: Erlotinib Start Date: 2014-02 Last Updated: 2017-06-22 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT06124391
Title: Novel Subtypes of Polycystic Ovary Syndrome Study Summary: To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes. Sponsor: Shandong University Intervention: Long-term follow-up Start Date: 2021-01-01 Last Updated: 2023-11-09 Number of Patients: 50000 Recruitment Status: RECRUITING Condition: Polycystic Ovary Syndrome
NCTID: NCT04182204
Title: A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Study Summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT). Sponsor: Hoffmann-La Roche Intervention: Polatuzumab Vedotin Start Date: 2020-02-07 Last Updated: 2023-11-18 Number of Patients: 267 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT02008227
Title: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy Study Summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-03-11 Last Updated: 2019-12-20 Number of Patients: 1225 Recruitment Status: COMPLETED Condition: Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT00381368
Title: Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients Study Summary: The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases. Sponsor: University of Turku Intervention: Ibandronic acid Start Date: 2006-10 Last Updated: 2006-12-04 Number of Patients: 60 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT01212991
Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2010-09-16 Last Updated: 2020-03-17 Number of Patients: 1717 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01601691
Title: Protection of Rectum From High Radiation Doses Study Summary: The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy. Sponsor: University of Oulu Intervention: DuraSeal Start Date: 2012-04 Last Updated: 2014-11-14 Number of Patients: 10 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT00646854
Title: Alemtuzumab and CHOP in T-cell Lymphoma Study Summary: The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma. Sponsor: Aarhus University Hospital Intervention: CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab Start Date: 2008-06 Last Updated: 2019-03-01 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Lymphoma, T-Cell, Peripheral
NCTID: NCT05630950
Title: LDCT-SC-FI Low-dose CT Screening for Lung Cancer Study Summary: This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention). Sponsor: Oulu University Hospital Intervention: Smoking cessation mobile application Start Date: 2022-11-18 Last Updated: 2023-10-04 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer Screening
NCTID: NCT05429268
Title: Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) Study Summary: The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Sponsor: Incyte Corporation Intervention: Tafasitamab Start Date: 2022-12-23 Last Updated: 2023-11-24 Number of Patients: 81 Recruitment Status: RECRUITING Condition: Large B-Cell Lymphoma
NCTID: NCT04737590
Title: Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts Study Summary: The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland. Sponsor: Turku University Hospital Intervention: Bioactive glass Start Date: 2012-09-05 Last Updated: 2021-02-04 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Bone Cysts
NCTID: NCT02319837
Title: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Study Summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2014-12-17 Last Updated: 2023-08-08 Number of Patients: 1068 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hormone Sensitive Prostate Cancer
NCTID: NCT03155997
Title: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2017-07-12 Last Updated: 2023-07-14 Number of Patients: 5637 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01347697
Title: Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer Study Summary: The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: * a technique using a gluteus maximus myocutaneous flap or * a technique using an acellular porcine collagen implant (biological mesh) The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap. The study is interventional, randomized and by definition a comparative effectiveness research project. Sponsor: Umeå University Intervention: Reconstruction with an acellular porcine dermal collagen implant (biological mesh) Start Date: 2011-09-05 Last Updated: 2023-05-03 Number of Patients: 91 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectal Cancer
NCTID: NCT03395197
Title: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Study Summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. Sponsor: Pfizer Intervention: Talazoparib with enzalutamide Start Date: 2017-12-18 Last Updated: 2023-08-02 Number of Patients: 1125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: mCRPC
NCTID: NCT01790737
Title: First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 Study Summary: The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety. Sponsor: Kuopio University Hospital Intervention: Cyclophosphamide Start Date: 2013-01 Last Updated: 2019-03-01 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT03022747
Title: Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol Study Summary: The study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity. Sponsor: Vastra Gotaland Region Intervention: Allopurinol Start Date: 2017-01 Last Updated: 2017-01-16 Number of Patients: 60 Recruitment Status: UNKNOWN Condition: Lymphoblastic Leukemia, Acute, Childhood
NCTID: NCT04332822
Title: A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma Study Summary: This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026. Sponsor: Nordic Lymphoma Group Intervention: R-pola-mini-CHP Start Date: 2020-08-19 Last Updated: 2021-07-09 Number of Patients: 200 Recruitment Status: RECRUITING Condition: DLBCL
NCTID: NCT03155100
Title: Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines Study Summary: The main aim of this study is to assess the ORR with a new drug combination, carfilzomib (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex). Sponsor: Raija Silvennoinen Intervention: Carfilzomib for Inj 60 milligram (MG) Start Date: 2017-08-07 Last Updated: 2023-09-26 Number of Patients: 15 Recruitment Status: COMPLETED Condition: Multiple Myeloma in Relapse
NCTID: NCT05214183
Title: Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma Study Summary: This is a phase II trial, with the aim of developing a chemotherapy-free regimen for untreated patients with mantle cell lymphoma (MCL). Acalabrutinib (ACP-196) is a next generation bruton tyrosine kinase (BTK) inhibitor, more selective than ibrutinib, and without in vitro antagonism of anti-CD20 directed immunotherapies, indicating that its combination with rituximab may be more active than the combination of ibrutinib and rituximab. In this trial proposal, we will also assess the activity of this combination in comparison to a historical control of ibrutinib + rituximab, consisting of the experimental arm of ibrutinib + rituximab in the randomized ENRICH trial (EudraCT number 2015-000832-13), and data from our previous trial with R-bendamustine-lenalidomide (NLG-MCL4). The duration of treatment will be a minimum of 12 months. Patients in molecular remission in blood and bone marrow and in complete remission according to CT, will then stop acalabrutinib, but continue on rituximab for a maximum of 36 months. Patients that are minimal residual disease positive (MRD+) will be evaluated again every 6 months and continue on acalabrutinib for a maximum of 36 months. Patients without a molecular marker, that cannot be followed with MRD, will stop treatment if in CR with PET at 12 months, and be followed by PET-CT every 6 months for a maximum of 36 months. Patients who convert back to MRD positive after stopping acalabrutinib are reinstalled on acalabrutinib until progression. Patients with TP53 aberrations and/or blastoid histology, will monitor MRD but continue with treatment until progression regardless of MRD results. A planned interim analysis will be performed when 40 patients have undergone response assessment after 6 months, for futility and efficacy. If less than 16 of 40 patients obtain a CR, the trial will be stopped due to futility. Sponsor: Nordic Lymphoma Group Intervention: Acalabrutinib-rituximab in patients with untreated mantle cell lymphoma Start Date: 2021-12-15 Last Updated: 2022-02-14 Number of Patients: 80 Recruitment Status: RECRUITING Condition: MCL
NCTID: NCT00308607
Title: Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma Study Summary: The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma. Sponsor: University of Turku Intervention: Bevacizumab (Avastin) Start Date: 2005-08 Last Updated: 2009-04-03 Number of Patients: 27 Recruitment Status: COMPLETED Condition: Metastatic Melanoma
NCTID: NCT04557059
Title: A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer Study Summary: The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone. Sponsor: Janssen Pharmaceutica N.V., Belgium Intervention: Radiotherapy Start Date: 2020-11-12 Last Updated: 2023-11-09 Number of Patients: 412 Recruitment Status: RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT05514054
Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2022-10-04 Last Updated: 2023-10-24 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT01649856
Title: A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma Study Summary: This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months. Sponsor: Hoffmann-La Roche Intervention: CHOP Start Date: 2012-08-24 Last Updated: 2017-10-11 Number of Patients: 572 Recruitment Status: COMPLETED Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT05317416
Title: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant Study Summary: The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years Sponsor: Pfizer Intervention: Elranatamab Start Date: 2022-03-25 Last Updated: 2023-11-03 Number of Patients: 760 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT04392505
Title: Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study Study Summary: The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics. Sponsor: Oslo University Hospital Intervention: Durvalumab Injection Start Date: 2020-05-11 Last Updated: 2022-10-25 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT05063682
Title: The Efficacy and Safety of Brain-targeting Immune Cells (EGFRvIII-CAR T Cells) in Treating Patients With Leptomeningeal Disease From Glioblastoma. Administering Patients EGFRvIII -CAR T Cells May Help to Recognize and Destroy Brain Tumor Cells in Patients Study Summary: This phase I trial investigates the efficacy and safety of brain-targeting epidermal growth factor receptor chimeric antigen receptor immune cells (EGFRvIII-CAR T cells) in treating patients with leptomeningeal disease from glioblastoma. T cells are part of the immune system and help the body fight malignant tumours. Immune cells can be genetically modified to destroy brain tumor cells in the laboratory. EGFRvIII -CAR T cells are brain tumor specific and can enter and express its genes in immune cells. Administering patients EGFRvIII -CAR T cells may help to recognize and destroy brain tumor cells in patients with leptomeningeal disease from glioblastoma. Sponsor: Chembrain LTD Intervention: EGFRvIII-specific hinge-optimized CD3 ζ-stimulatory/41BB-co-stimulatory Chimeric Antigen Receptor autologous T-lymphocytes Start Date: 2020-05-15 Last Updated: 2021-10-01 Number of Patients: 10 Recruitment Status: UNKNOWN Condition: Glioblastoma
NCTID: NCT03850795
Title: HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study Summary: This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected. Sponsor: Hinova Pharmaceuticals USA, Inc. Intervention: HC-1119 Start Date: 2021-03-15 Last Updated: 2023-09-22 Number of Patients: 104 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer Metastatic
NCTID: NCT03376672
Title: Ixazomib Plus Lenalidomide Plus Dexamethasone for Newly Diagnosed Myeloma Patients Study Summary: This study will evaluate the efficacy and safety of 3-drug all-oral combination, ixazomib plus lenalidomide plus dexamethasone (IRd) as induction treatment for autologous stem cell transplantation eligible patients followed by IRd consolidation and risk based maintenance treatment with IR or R alone. Sponsor: Raija Silvennoinen Intervention: Ixazomib Start Date: 2018-05-31 Last Updated: 2023-09-26 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT01379989
Title: INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer Study Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Carboplatin Start Date: 2011-06 Last Updated: 2022-02-09 Number of Patients: 617 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04725188
Title: Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002) Study Summary: The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab coformuation Start Date: 2021-04-20 Last Updated: 2023-07-06 Number of Patients: 255 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT03733990
Title: A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS) Study Summary: This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity. The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients. Sponsor: Faron Pharmaceuticals Ltd Intervention: FP-1305 (bexmarilimab) Start Date: 2018-12-03 Last Updated: 2023-11-27 Number of Patients: 216 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT02504346
Title: AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies Study Summary: Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed following treatment with an approved epidermal growth factor tyrosine kinase inhibitor agent. Sponsor: Oslo University Hospital Intervention: AZD9291 Start Date: 2015-08 Last Updated: 2023-03-28 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer
NCTID: NCT00116753
Title: A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer Study Summary: The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix. Sponsor: Ferring Pharmaceuticals Intervention: Degarelix Start Date: 2005-01 Last Updated: 2010-12-10 Number of Patients: 460 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01588873
Title: Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome Study Summary: The main aims of this study are: * to investigate and compare the effects of long lasting use (59 weeks) of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS. * to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women, for example in women with increased metabolic risks. * to clarify whether the unfavourable effects of combined contraceptives diminish with time (after use of one year). Sponsor: University of Oulu Intervention: oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel Start Date: 2012-04 Last Updated: 2012-05-04 Number of Patients: 42 Recruitment Status: UNKNOWN Condition: Adverse Effect of Oral Contraceptives, Sequela
NCTID: NCT04628494
Title: A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL Study Summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT Sponsor: Genmab Intervention: Epcoritamab Start Date: 2021-01-13 Last Updated: 2023-08-07 Number of Patients: 552 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03495960
Title: Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System Study Summary: Primary central nervous system lymphomas are rare aggressive malignancies, usually treated in two steps: an induction phase (where a combination of chemotherapy is given) followed by a consolidation phase (where patients usually receive one of the following: whole-brain irradiation, chemotherapy supported by autologous stem-cell transplantation, other type of chemotherapy, or are just observed). The feasibility of this overall strategy, for several reasons, is limited in elderly patients . This study involves patients aged ≥70 years. The more fit patients will receive the standard chemotherapy combination (high-dose methotrexate, procarbazine and rituximab) as induction. Responding patients will receive either procarbazine or lenalidomide as maintenance therapy; the aim is to evaluate the efficacy of these two drugs. The more fragile patients will receive a less aggressive therapy consisting of concomitant whole-brain radiotherapy, temozolomide and rituximab as induction therapy, followed by temozolomide as maintenance treatment; the aim is to evaluate the efficacy of this combination of treatment. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Rituximab Start Date: 2019-06-15 Last Updated: 2023-05-18 Number of Patients: 208 Recruitment Status: RECRUITING Condition: Primary Central Nervous System Lymphoma
NCTID: NCT04778878
Title: Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device Study Summary: The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen. Sponsor: Oulu University Hospital Intervention: Mediracer® NCS Start Date: 2019-10-01 Last Updated: 2021-03-03 Number of Patients: 12 Recruitment Status: UNKNOWN Condition: Cancer
NCTID: NCT02626455
Title: Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) Study Summary: The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine \[R-B\] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone \[R-CHOP\]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents. Sponsor: Bayer Intervention: Copanlisib (BAY80-6946) Start Date: 2016-01-06 Last Updated: 2023-10-12 Number of Patients: 551 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma, Non-Hodgkin
NCTID: NCT03527784
Title: Prestoma-Trial for Parastomal Hernia Prevention Study Summary: Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma. Sponsor: University of Oulu Intervention: Parietene Macro Start Date: 2018-05-03 Last Updated: 2018-11-05 Number of Patients: 14 Recruitment Status: TERMINATED Condition: Rectal Adenocarcinoma
NCTID: NCT03911128
Title: A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia Study Summary: The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol. Sponsor: Mats Heyman Intervention: Observational Start Date: 2019-08-29 Last Updated: 2023-08-30 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Leukemia, Acute Lymphoblastic
NCTID: NCT00976911
Title: AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer Study Summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2009-10-29 Last Updated: 2022-06-21 Number of Patients: 361 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT00980213
Title: Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland Study Summary: Patient receiving sunitinib according the clinician's independent decision as first-line treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent. Treatment with sunitinib will start and end solely on the treating clinicians and the patients independent discretion. Consenting patients will prospectively answer standardized quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care resource utilisation will be collected prospectively (outpatient visits, hospital stays, concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment failure anti-cancer drugs, hospital stays and date of death will be recorded. The health economic data during sunitinib treatment and the length of the sunitinib treatment will be compared with the corresponding previously published data collected retrospectively from patients with the same condition treated with IFN-alfa. Stepwise regression analysis will be used to explore whether patient and tumor characteristics explain potential variation in treatment duration and costs that is not explained by the treatment. Health-related quality of life (HRQoL) data will be presented as descriptive data and compared to age-standardized general population. At least four major Finnish oncology centers have consented to participate in this study. The inclusion time will be approximately 24 months, and the study time approximately 48 months. Eighty patients will be included. Sponsor: Pirkko-Liisa Kellokumpu-Lehtinen Intervention: sunitinib Start Date: 2009-09 Last Updated: 2014-02-06 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04313881
Title: Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Study Summary: The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS). Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2020-09-09 Last Updated: 2023-09-25 Number of Patients: 539 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndromes
NCTID: NCT04221035
Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vincristine Start Date: 2019-11-05 Last Updated: 2023-02-13 Number of Patients: 800 Recruitment Status: RECRUITING Condition: High-Risk Neuroblastoma
NCTID: NCT01995513
Title: Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients Study Summary: The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2013-10-22 Last Updated: 2023-09-18 Number of Patients: 509 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03445936
Title: PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure Study Summary: This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure. Sponsor: University of Oulu Intervention: Parietene Macro Start Date: 2018-02-13 Last Updated: 2021-10-07 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectum Cancer
NCTID: NCT03863236
Title: A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri Study Summary: This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) used at least 2 weeks prior the surgery and 10 days after surgery can improve the nutritional status of a colon cancer patient and reduce number of complications. The aim is also to investigate whether the oral nutritional support can shorten the hospital stay and improve the patients´ quality of life. The aim is also to find out whether the oral nutritional support can reduce 90-day mortality and improve disease free and overall survival. Consecutive patients diagnosed with primary adenocarcinoma of the colon who are considered for radical surgical procedure are enrolled in this study provided that the inclusion criteria are filled. Patients in the intervention group start oral nutritional support (ONS)2 portions a day for about 2 weeks prior to the operation starting at the time of randomization and continue ONS 10 days after the operation. Control group will continue with their regular diet without ONS until the operation. Both groups keep a food diary for 4 days right after the randomization and both one month and three months after the operation to assess the energy and nutrient intakes. Laboratory markers, NRS 2002, quality of life questionnaire, exercise questionnaire, bioelectrical impedance analysis (BIA) and handgrip strength as well as body composition on computer tomography scan are assessed prior to any treatment or supplement in order to estimate the patients' well-being and nutritional status prior to surgical operation. Laboratory parameters and QoL questionnaire are repeated right before the operation on admission to hospital as well as about 30 and 90 days after the operation in addition to BIA, handgrip strength to assess the effect of nutritional support. Data on complications, infections, length of stay in the hospital and mortality are collected. Another arm in this research is to discover more information on biological markers in colon cancer and cancer related malnutrition thus providing targets for future treatment and prognostic predictors. Tissue samples are collected during this research at the surgery. Sponsor: University of Oulu Intervention: regular diet Start Date: 2019-04-01 Last Updated: 2022-05-18 Number of Patients: 318 Recruitment Status: RECRUITING Condition: Colon Cancer
NCTID: NCT05239728
Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2022-03-15 Last Updated: 2023-11-18 Number of Patients: 1800 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT05020236
Title: MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Study Summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. Sponsor: Pfizer Intervention: Elranatamab Start Date: 2021-10-04 Last Updated: 2023-08-24 Number of Patients: 854 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT01317641
Title: Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer Study Summary: The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer. Sponsor: Orion Corporation, Orion Pharma Intervention: ODM-201 Start Date: 2011-03 Last Updated: 2017-03-29 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT02807636
Title: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-06-30 Last Updated: 2023-06-09 Number of Patients: 1213 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT03142334
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) Study Summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2017-06-09 Last Updated: 2023-06-29 Number of Patients: 994 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT04081558
Title: Electronic Symptom Follow-up of Cancer Patients Study Summary: Use of ePROs in oncological care have resulted in improvement of QoL, decreased ER visits, and improvement of overall survival. Furthermore, ePRO follow-up resulted in better QoL, improved ECOG status and more active cancer treatments at disease relapse, and improved survival among cancer survivals. The current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving chemotherapies or targeted therapies. The aims of the current study are: 1) The number of alerts triggered by Kaiku Cancer medical treatment side-effects questionnaire and their correlation to treatment side-effects, other relevant medical events, tumor progression, and survival 2) Changes in Kaiku QLQ-C30 QoL questionnaire and their correlation to cancer treatment response, side-effects, other relevant medical event or survival 3) Patient compliance to Kaiku ePRO surveillance during treatment period according to response rates of Patient experience survey, Kaiku Cancer medical treatment side-effects questionnaire and Kaiku QLQ-C30 QoL questionnaire In addition, in the CRC (colorectal cancer) cohort: 1. Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle 2. Number of phone calls related to prescribing a new chemotherapy cycle 3. Unscheduled doctor appointments in oncology unit 4. ER visits 5. Days in hospitalization 6. Unscheduled investigations in health care 7. Development of peripheral neurotoxicity 8. The number of chemotherapy dose reductions 9. The number of chemotherapy delays 10. Health care user experience survey Sponsor: Oulu University Hospital Intervention: Electronic patient reported outcomes tool Start Date: 2018-01-01 Last Updated: 2021-02-24 Number of Patients: 100 Recruitment Status: UNKNOWN Condition: Cancer
NCTID: NCT04731558
Title: Pre- vs Postoperative Thromboprophylaxis for Liver Resection Study Summary: Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial. Sponsor: Helsinki University Central Hospital Intervention: enoxaparin or tinzaparin or dalteparin Start Date: 2021-02-10 Last Updated: 2022-09-22 Number of Patients: 1012 Recruitment Status: RECRUITING Condition: Liver Cancer
NCTID: NCT04043494
Title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma Study Summary: Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02) Sponsor: University Hospital Muenster Intervention: Cyclophosphamide Start Date: 2019-08-23 Last Updated: 2022-12-16 Number of Patients: 683 Recruitment Status: RECRUITING Condition: Lymphoblastic Lymphoma, Childhood
NCTID: NCT01429064
Title: Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001 Study Summary: The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer. Sponsor: Orion Corporation, Orion Pharma Intervention: ODM-201 Start Date: 2011-06 Last Updated: 2017-02-20 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT05171777
Title: A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer Study Summary: This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2022-04-04 Last Updated: 2023-11-13 Number of Patients: 176 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT05654623
Title: A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. Study Summary: A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer. Sponsor: Pfizer Intervention: ARV-471 Start Date: 2023-03-03 Last Updated: 2023-09-21 Number of Patients: 560 Recruitment Status: RECRUITING Condition: Advanced Breast Cancer
NCTID: NCT05224141
Title: Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008) Study Summary: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2022-03-24 Last Updated: 2023-10-10 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT04740918
Title: A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) Study Summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2021-06-07 Last Updated: 2023-11-18 Number of Patients: 96 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT03505944
Title: Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma Study Summary: Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of rituximab-lenalidomide in patients with relapsed/refractory MCL. Sponsor: Nordic Lymphoma Group Intervention: Venetoclax Start Date: 2018-07-01 Last Updated: 2021-10-13 Number of Patients: 59 Recruitment Status: UNKNOWN Condition: Relapsed Non Hodgkin Lymphoma
NCTID: NCT04303780
Title: Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation Sponsor: Amgen Intervention: AMG 510 Start Date: 2020-06-04 Last Updated: 2023-10-23 Number of Patients: 345 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
NCTID: NCT02003924
Title: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2013-10-31 Last Updated: 2023-10-10 Number of Patients: 1401 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Nonmetastatic Castration-Resistant Prostate Cancer
NCTID: NCT01828489
Title: Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years Study Summary: This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome). Sponsor: Vastra Gotaland Region Intervention: Randomisation course 1 mitoxantrone versus DaunoXome Start Date: 2013-03 Last Updated: 2017-01-10 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: Pediatric Acute Myeloblastic Leukemia
NCTID: NCT02477644
Title: Platine, Avastin and OLAparib in 1st Line Study Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance. Sponsor: Arcagy Research Intervention: Olaparib Start Date: 2015-05-06 Last Updated: 2022-08-02 Number of Patients: 806 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04307576
Title: A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia Study Summary: ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design. Sponsor: Mats Heyman Intervention: Omitted Doxorubicin Start Date: 2020-07-13 Last Updated: 2023-11-21 Number of Patients: 6430 Recruitment Status: RECRUITING Condition: Leukemia, Acute Lymphoblastic
NCTID: NCT04260269
Title: Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study Study Summary: The purpose of the present study is to evaluate cardiotoxicity during re-challenge of a different modality of fluoropyrimidine (primary end-point S-1 and secondary any other fluoropyrimidine) after having perceived cardiotoxicity with a fluoropyrimidine based regimen previously. The patient population is being treated for solid tumors. Sponsor: Helsinki University Central Hospital Intervention: Fluoropyrimidine Start Date: 2018-06-01 Last Updated: 2020-02-07 Number of Patients: 200 Recruitment Status: ENROLLING_BY_INVITATION Condition: Solid Tumor
NCTID: NCT00669370
Title: Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer Study Summary: To determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine. Secondary endpoints are time to progression, overall response rate and overall survival. Study treatment will continue until disease progression or unacceptable toxicity. Sponsor: University of Turku Intervention: docetaxel and capecitabine Start Date: 2006-06 Last Updated: 2008-04-30 Number of Patients: 50 Recruitment Status: UNKNOWN Condition: Stomach Neoplasms
NCTID: NCT05428969
Title: A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies (BEXMAB) Study Summary: This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1. Sponsor: Faron Pharmaceuticals Ltd Intervention: Bexmarilimab Start Date: 2022-06-02 Last Updated: 2023-06-23 Number of Patients: 181 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
