Trials (Institut Jules Bordet)

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NCTID: NCT04966715

Title: Inferior Epigastric Lymph Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Colorectal Peritoneal Metastases
Study Summary: In this study, the investigators propose to systematically collect and analyse epigastric lymph nodes during complete cytureductive surgery in patients with colorectal carcinomatosis, in order to define their role in the dissemination of colorectal metastases
Sponsor: Jules Bordet Institute
Intervention: Epigastric lymph node biopsy
Start Date: February 3, 2022
Last Updated: October 5, 2023
Number of Patients: 40
Recruitment Status: Recruiting
Condition: Colorectal Carcinomatosis

NCTID: NCT04379817

Title: Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Study Summary: This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.
Sponsor: Jules Bordet Institute
Intervention: Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
Start Date: February 25, 2020
Last Updated: March 28, 2023
Number of Patients: 20
Recruitment Status: Recruiting
Condition: Multiple Myeloma

NCTID: NCT01709487

Title: Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
Study Summary: First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.
Sponsor: Jules Bordet Institute
Intervention: HIPEC
Start Date: May 2010
Last Updated: February 24, 2016
Number of Patients: 19
Recruitment Status: Completed
Condition: Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

NCTID: NCT01481701

Title: A Non Randomized Stratified Phase II Trial Evaluating Efficacy and Safety of Oxaliplatin in Combination With 5-Fluorouracil in Patients With Platinum-sensitive and Platinum-resistant Recurrent Ovarian Carcinoma
Study Summary: This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.
Sponsor: Jules Bordet Institute
Intervention: Oxaliplatin, oxaliplatin
Start Date: October 2008
Last Updated: October 15, 2014
Number of Patients: 90
Recruitment Status: Completed
Condition: Ovarian Carcinoma, Relapse

NCTID: NCT01686880

Title: Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
Study Summary: The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
Sponsor: Jules Bordet Institute
Intervention: Sirsphere trans-arterial radioembolization
Start Date: September 2012
Last Updated: July 1, 2015
Number of Patients: 10
Recruitment Status: Terminated
Condition: Hepatocellular Carcinoma, Liver Cirrhosis

NCTID: NCT01929616

Title: Regorafenib Assessment in Refractory Advanced Colorectal Cancer
Study Summary: The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.
Sponsor: Jules Bordet Institute
Intervention: regorafenib
Start Date: August 2013
Last Updated: June 25, 2019
Number of Patients: 141
Recruitment Status: Completed
Condition: Advanced Chemorefractory Colorectal Adenocarcinoma

NCTID: NCT02655965

Title: A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption
Study Summary: The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a \"pecs block\" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).
Sponsor: Jules Bordet Institute
Intervention: Ropivacaine, Clonidine, Sodium Chloride
Start Date: May 2016
Last Updated: January 27, 2021
Number of Patients: 54
Recruitment Status: Completed
Condition: Locoregional Analgesia in Breast Surgery

NCTID: NCT01290926

Title: Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer
Study Summary: Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders.
Sponsor: Jules Bordet Institute
Intervention: chemotherapy
Start Date: February 2011
Last Updated: February 24, 2016
Number of Patients: 97
Recruitment Status: Completed
Condition: Colorectal Cancer

NCTID: NCT06052332

Title: Efficacy and Safety of Short-course Radiotherapy (SCRT) Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial
Study Summary: The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.
Sponsor: Jules Bordet Institute
Intervention: Short course radiotherapy, Adjuvant chemotherapy (optional), Total mesorectal excision, Total neoadjuvant therapy
Start Date: December 2023
Last Updated: September 25, 2023
Number of Patients: 230
Recruitment Status: Not yet recruiting
Condition: Locally Advanced Rectal Cancer, Older People

NCTID: NCT02028364

Title: Pet Imaging as a Biomarker of Everolimus Added Value in Hormone Refractory postmenopausaL Women
Study Summary: This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction with exemestane 25mg orally daily until disease progression or treatment discontinuation for any other reasons. The main objectives are to evaluate if early metabolic response (MR) using FDG-PET/CT is associated with progression free survival (PFS) and overall survival (OS) in this population. Tumour, metastatic lesions and blood samples will be collected during the treatment period in order to identify biomarkers predicting resistance to study treatment. Results will be correlated with the results of early FDG PET/CT data in order to better characterise the non-responders.
Sponsor: Jules Bordet Institute
Intervention: Everolimus, Exemestane
Start Date: January 12, 2014
Last Updated: August 24, 2023
Number of Patients: 55
Recruitment Status: Completed
Condition: Breast Cancer

NCTID: NCT02032498

Title: Evaluation of Near- InfraRed Imaging of ICG in Comparison With the Lymphoscintigraphic Technique Using Intramammary and Peritumoral Injection of 99mTc-HSA-Nanocolloids for the SLN Detection in BC Patients
Study Summary: The revision of our data shows that since its introduction in our institution (Jules Bordet Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional axillary dissection. The analysis of these cases shows that: The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is associated in 75% of them with a pN+ status If scintigraphic imaging is \"positive\" (demonstration of the sentinel lymph nodes: 35 cN0 and 10 cN+), our results appear favorable with a single false negative SLN result (False Negative Rate = 1/20 or 5%). Therefore we propose additional technique for LN detection by indocyanine green, we hypothesize that the combination of two different injections improves the technique of sentinel lymph node biopsy.
Sponsor: Jules Bordet Institute
Intervention: Indocyanine Green
Start Date: July 2013
Last Updated: July 24, 2014
Number of Patients: 214
Recruitment Status: Unknown status
Condition: Breast Cancer

NCTID: NCT00994864

Title: Preoperative Chemosensitivity Testing as Predictor of Treatment Benefit in Adjuvant Stage III Colon Cancer: PePiTA Trial
Study Summary: The primary working hypothesis is that preoperative chemo-sensitivity testing using fluorodeoxyglucose positron emission tomography (FDG-PET) performed before and after one course of FOLFOX (folinic acid, fluorouracil, oxaliplatin) can identify the patients that will least likely have a significant benefit from adjuvant FOLFOX for stage III colon cancer. The benefit will be analyzed by correlating the preoperative FDG-PET uptake changes to the disease free and overall survival.
Sponsor: Jules Bordet Institute
Intervention: FOLFOX
Start Date: November 2009
Last Updated: August 7, 2023
Number of Patients: 235
Recruitment Status: Completed
Condition: Colon Cancer

NCTID: NCT01864798

Title: A Pre-Operative Window Study Evaluating Denosumab, a RANKligand (RANKL) Inhibitor and Its Biological Effects in Young Premenopausal Women Diagnosed With Early Breast Cancer
Study Summary: This is a prospective, single arm phase IIa trial in which patients with early breast cancer will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be collected at baseline and at surgery. Post-operative treatment will be at the discretion of the investigator. Primary objective: to determine if a short course of RANKL inhibition with denosumab can induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women. Secondary objectives: To determine the number of absolute Ki67 responders after a short course of denosumab (defined as <2.7% IHC staining in the post treatment tumor biopsy). To determine the effects of a short course of denosumab on serum C-terminal telopeptide levels (CTX). To determine the effects of a short course of denosumab on RANK/RANKL gene expression and signaling as assessed by immunohistochemistry (IHC) and RNA sequencing in the tumor. To determine the effect of a short course of denosumab on tumor apoptosis rates using IHC To determine the effect of a short course of denosumab on modulating the immature mammary epithelial cell populations in the tumor. To determine the effect of a short course of denosumab on estrogen signaling pathways in the tumor. To determine the effect of a short course of denosumab on various immune To determine effect of safety profile of denosumab
Sponsor: Jules Bordet Institute
Intervention: Denosumab
Start Date: July 2013
Last Updated: November 27, 2018
Number of Patients: 27
Recruitment Status: Terminated
Condition: Breast Neoplasms

NCTID: NCT04675827

Title: De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade
Study Summary: DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator's discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).
Sponsor: Jules Bordet Institute
Intervention: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
Start Date: January 17, 2022
Last Updated: September 5, 2023
Number of Patients: 1065
Recruitment Status: Suspended
Condition: HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer

NCTID: NCT03674424

Title: Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers
Study Summary: Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC). Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.
Sponsor: Jules Bordet Institute
Intervention: Avelumab, cystectomy, CG, DD-MVAC, PG
Start Date: June 1, 2018
Last Updated: September 29, 2023
Number of Patients: 137
Recruitment Status: Active, not recruiting
Condition: Non-metastatic Muscle Invasive Bladder Cancer

NCTID: NCT03339843

Title: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib
Study Summary: Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria. Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage: Platinum-refractory esophageal adenocarcinoma (ADC) Platinum-refractory esophageal squamous cell carcinoma (SCC) Platinum-refractory cholangiocarcinoma Platinum-refractory and progressive after immunotherapy urothelial cancer Platinum-refractory endometrial cancer
Sponsor: Jules Bordet Institute
Intervention: Abemaciclib
Start Date: December 19, 2018
Last Updated: July 10, 2023
Number of Patients: 85
Recruitment Status: Active, not recruiting
Condition: Esophageal Adenocarcinoma, Esophagus SCC, Cholangiocarcinoma, Urothelial/Bladder Cancer, Nos, Endometrial Cancer

NCTID: NCT04726358

Title: ProCaLung - Project on Cancer of the Lung : A National Radiotherapy Quality Assurance for Stage III NSCLC
Study Summary: ProCaLung is a national registry collecting radiation treatment parameters of patients having lung cancer that extends to mediastinal lymph nodes. The project includes a peer review activity. The purpose of this public health program is similar to an audit whose objective is to promote quality of radiation oncology in Belgium. It is run by Institut Jules Bordet on behalf of the College of Physicians for Radiotherapy Centers of the Belgian Health Federal Public Service, in close collaboration with the Belgian Cancer Registry. All Belgian radiotherapy centers are invited to participate in ProCaLung but their participation is not mandatory. The centers who accept to participate show a commitment to quality assurance as the radiotherapy-treatment-related parameters they generate will be analyzed to establish national statistics. It includes a peer-review process based on international guidelines for mediastinal nodes delineations given for informational purposes. The public interest program also collects technical parameters as they were planned and delivered during the course of chest radiation treatment. This includes the delineations of tumors, nodes and chest organs on simulation-CT images, PET/CT images, chest-CT images and the clinical information related to the lung cancer. Results/statistics will be published at the end of the project.
Sponsor: Jules Bordet Institute
Intervention: character(0)
Start Date: October 1, 2021
Last Updated: June 12, 2023
Number of Patients: 1000
Recruitment Status: Recruiting
Condition: Locally Advanced Lung Carcinoma

NCTID: NCT03616886

Title: A Phase I/II Study of Paclitaxel Plus Carboplatin and Durvalumab (MEDI4736) With or Without Oleclumab (MEDI9447) for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
Study Summary: The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach. CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade. The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab [anti-PD-L1] +/- MEDI9447 [anti-CD73]) in previously untreated locally recurrent inoperable or metastatic TNBC. A large translational research program is planned including baseline and dynamic biomarkers
Sponsor: Jules Bordet Institute
Intervention: Paclitaxel, Carboplatin, MEDI4736, MEDI9447
Start Date: December 28, 2018
Last Updated: September 21, 2023
Number of Patients: 129
Recruitment Status: Active, not recruiting
Condition: Triple Negative Breast Cancer

NCTID: NCT04551495

Title: Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast
Study Summary: Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.
Sponsor: Jules Bordet Institute
Intervention: Entrectinib, Letrozole, Goserelin
Start Date: January 14, 2021
Last Updated: April 18, 2023
Number of Patients: 65
Recruitment Status: Recruiting
Condition: Invasive Lobular Breast Carcinoma, ER+ Breast Cancer, HER2-negative Breast Cancer

NCTID: NCT03875573

Title: Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer: a Phase ll Randomised Trial
Study Summary: Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms: the combination of weekly paclitaxel followed by dose-dense doxorubicin-cyclophosphamide (ddAC) and pre-operative radiation therapy (boost dose) on the primary tumour arm 1 with the addition of the anti-PD-L1 antibody durvalumab arm 2 with the addition of the anti-CD73 antibody oleclumab The primary tumour will be excised 2-6 weeks after completion of ddAC. A safety run-in is planned for the 6 first subjects before starting the randomized phase II trial. Those 6 subjects will receive the treatment given in Arm 3.
Sponsor: Jules Bordet Institute
Intervention: Durvalumab, Stereotactic Body Radiotherapy, Oleclumab
Start Date: November 6, 2019
Last Updated: November 9, 2023
Number of Patients: 147
Recruitment Status: Recruiting
Condition: Luminal B

NCTID: NCT04503694

Title: A Phase II Trial of Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer
Study Summary: This is a multicenter, single-arm, phase II study of nivolumab in combination with regorafenib in subjects with locally-advanced rectal cancer who are eligible for a curative treatment including pre-operative SCRT and TME(or watch & wait approach). The study is based on the Simon's two-stage design and a maximum of 60 subjects will be enrolled. In addition to the standard efficacy interim analysis according to the statistical design, a safety interim analysis will be performed on the first 6 subjects who have completed the study treatment to ensure safe continuation of the study investigation. Eligible subjects will be treated according to the following sequential treatment plan: Induction treatment: This consists of treatment with nivolumab (240 mg intravenously, on day 1 and 15) and regorafenib (80 mg/day orally, from day 1 to 14) Standard SCRT: This consists of 25 Gy delivered in 5 fractions (from day 22 to 26) Consolidation treatment: This consists of treatment with nivolumab (240 mg intravenously, on day 29, 43 and 57) and regorafenib (80 mg/day orally, from day 29 to 49) Surgery: Surgical resection will be performed according to the principles of TME (between day 74 and 87, i.e., between 7 to 8 weeks after completion of SCRT). As an alternative to surgery, subjects who achieve cCR can be offered a watch & wait approach. Adjuvant chemotherapy: Administration of adjuvant chemotherapy will be left to the discretion of the treating physician The study also includes translational procedures (i.e. collection of tumour biopsies, blood samples and stool samples at pre-specified time points) for exploratory molecular and immune contexture analyses. These are mandatory for all study subjects.
Sponsor: Jules Bordet Institute
Intervention: Nivolumab 10 MG/ML Intravenous Solution, Regorafenib 40 MG Oral Tablet, Radiotherapy, Surgery, Non-operative Management
Start Date: March 25, 2021
Last Updated: September 22, 2023
Number of Patients: 60
Recruitment Status: Recruiting
Condition: Rectal Cancer Stage II, Rectal Cancer Stage III

NCTID: NCT03065621

Title: Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast Cancer
Study Summary: This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28). The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening.
Sponsor: Jules Bordet Institute
Intervention: Palbociclib
Start Date: July 5, 2017
Last Updated: April 19, 2023
Number of Patients: 100
Recruitment Status: Completed
Condition: Breast Cancer Female

NCTID: NCT04452032

Title: Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer
Study Summary: Multi-centric, one arm phase II study. The first phase of the study will consist of an evaluation of the initial dental state of each subject based on a stomatological examination, an orthopantomogram, two bitewing radiographs (right and left sides) and an evaluation of all potential risks of caries and fractures. For all of subjects, a dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment. Our previously developed predictive model for dental dose in function of the localisation of tumour and suspect lymph nodes based on the stomatological examination and on the pre-treatment imaging. An estimation of the intensity-modulated radiotherapy (IMRT) teeth dose will be made and translated into a colour based form of the pre-RT dental status. A contouring of the teeth will be performed and the planned dose for each tooth of each subject will be recorded by a dose volume histogram (DVH) curve based on the pre-treatment imaging. In the same way the mean dose and the V25 (the volume receiving 25 Gy) of the homo- and the heterolateral parotid gland will be calculated. Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT. After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as two bitewing radiographs. An orthopantomogram will be done once a year. Furthermore, periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.
Sponsor: Jules Bordet Institute
Intervention: Dental avulsion, Radiotherapy
Start Date: November 17, 2020
Last Updated: May 10, 2023
Number of Patients: 40
Recruitment Status: Active, not recruiting
Condition: Head and Neck Squamous Cell Carcinoma

NCTID: NCT01658956

Title: A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia
Study Summary: The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
Sponsor: Jules Bordet Institute
Intervention: GCSF administration on days 8 and 12 after chemotherapy
Start Date: July 2012
Last Updated: January 6, 2015
Number of Patients: 142
Recruitment Status: Unknown status
Condition: Breast Cancer

NCTID: NCT05865756

Title: Assessment of Radio(Chemo)Therapy-related Dysphagia in Head and Neck Cancer Patients Based on Cough-related Acoustic Features
Study Summary: To develop this objective and easily implementable assessment method of coughing based on acoustic features of voluntary and reflex coughs, there is a primary need in identifying and comparing acoustic cough features in healthy subjects and different disease-related coughs features. Cough is a common reason for seeking medical care. Chronic cough, defined as a cough that has lasted for longer that eight weeks, represents 10-38% of all referrals made to respiratory physicians [1-2]. Furthermore, between 60 and 80% of patients with chronic obstructivepulmonary disease (COPD) report cough. Following this pilot study comparing different populations, the applicability of the selected acoustic cough features should be examined in HNC patients with radiotherapy-induced dysphagia, Another frequent aspect of the clinical diagnostic examination of swallowing is perceptual analysis of voice quality immediately following deglutition. Changes in voice quality are assumed to provide information on the possible accumulation of saliva or food at the vocal folds level. It is reported that a change of voice may indicate laryngeal dysfunction or the presence of a foreign body at the laryngeal level [3] confirm that a normophonic voice after swallowing reflects a lack of aspiration-penetration. However, research shows that there is no strong correlation between aspiration and changes in perceptual voice quality (e.g. wet voice). A more reliable and easily implementable method could be detection of specific acoustic features of changes in voice quality.
Sponsor: Jules Bordet Institute
Intervention: Acoustic cough features analysis
Start Date: April 1, 2021
Last Updated: May 19, 2023
Number of Patients: 40
Recruitment Status: Recruiting
Condition: Head and Neck Cancer, Dysphagia

NCTID: NCT03307941

Title: Assessment of Metabolic and Pathological Response to Treatment With RCT and ImT Before Surgery in Locally Advanced Esophageal and Gastro-esophageal Junction Cancer: ARTemIS-Eso, a Three-level, Open-label, Phase I-II Study
Study Summary: ARTemIS-Eso is a phase I-II, three-level, open-label trial with a dose-expansion cohort at recommended schedule in both esophageal cancer histological groups (squamous cell carcinoma and adenocarcinoma) of RCT and ImT administered prior to surgery.
Sponsor: Jules Bordet Institute
Intervention: Monalizumab, Oxaliplatin, 5-Fluorouracil, Metabolic, Metabolic, Surgery
Start Date: July 20, 2017
Last Updated: December 19, 2017
Number of Patients: 0
Recruitment Status: Withdrawn
Condition: Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Squamous Cell Carcinoma of the Esophagus

NCTID: NCT00199134

Title: FRAGRANCE Trial(Femara Reanalysed Through Genomics for Response Assessment, Calibration and Empowerment)
Study Summary: Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;
Sponsor: Jules Bordet Institute
Intervention: Letrozole
Start Date: November 2004
Last Updated: January 6, 2015
Number of Patients: 49
Recruitment Status: Completed
Condition: Breast Cancer

NCTID: NCT01834469

Title: Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma
Study Summary: The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
Sponsor: Jules Bordet Institute
Intervention: iv injection of ICG
Start Date: March 2013
Last Updated: October 15, 2014
Number of Patients: 10
Recruitment Status: Completed
Condition: Ovarian Cancer, Peritoneal Carcinomatosis

NCTID: NCT02094742

Title: The BIG Molecular Screening Feasibility Study:Testing the IT Infrastructure and Logistics of a Molecular Screening Program
Study Summary: This pilot study examines the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. These assays will be performed using different laboratories and technologies from core biopsies taken from patients diagnosed with invasive recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated for ease of use to screen patients for participation in future molecularly defined clinical trials in breast cancer.
Sponsor: Jules Bordet Institute
Intervention: biopsy
Start Date: May 2013
Last Updated: October 15, 2014
Number of Patients: 30
Recruitment Status: Completed
Condition: Metastatic Breast Cancer

NCTID: NCT02053597

Title: A Phase II TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen Composed of Doxorubicin and Paclitaxel
Study Summary: Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women are inquiring into the possibility of preserving fertility following chemotherapy. The challenge remains in using a regimen that is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP) followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with convincing results regarding its effectiveness in the early setting, and could be potentially associated with less ovarian toxicity being devoid of cyclophosphamide.
Sponsor: Jules Bordet Institute
Intervention: Doxorubicin, paclitaxel
Start Date: October 2014
Last Updated: September 17, 2015
Number of Patients: 0
Recruitment Status: Withdrawn
Condition: Breast Cancer

NCTID: NCT05487248

Title: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients
Study Summary: COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician. Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.
Sponsor: Jules Bordet Institute
Intervention: Blood Sample Collection
Start Date: October 12, 2023
Last Updated: November 9, 2023
Number of Patients: 103
Recruitment Status: Recruiting
Condition: Unresectable Locally Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Candidate for Third-line or Subsequent Lines of Therapy

NCTID: NCT01842165

Title: The LuMEn Study: 177Lu-octreotate Treatment Outcome Prediction Using Multimodality Imaging in Refractory Neuroendocrine Tumours
Study Summary: The purpose of this study is to determine if 68Gallium-octreotate and 18Fluorodesoxyglucose uptake, apparent diffusion coefficient and post 177Lu-octreotate SPECT/CT dosimetry are reliable predictors for lesion-by-lesion treatment outcome.
Sponsor: Jules Bordet Institute
Intervention: Intravenous injection of 177Lu-octreotate
Start Date: May 2013
Last Updated: November 10, 2022
Number of Patients: 37
Recruitment Status: Completed
Condition: Gastroenteropancreatic Neuroendocrine Tumors

NCTID: NCT01565200

Title: Phase II Prospective Imaging Study Evaluating the Utility of Pre-treatment zr89 Labelled Trastuzumab PET/CT and an Early FDG-PET/CT Response to Identify Patients With Advanced HER2+ BC Unlikely to Benefit From a Novel antiHER2 Therapy: TDM1
Study Summary: T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35% objective response rate, 44% stable disease, 18% progressive disease) in patients with advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab and lapatinib. Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is \"key\" since the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the external domain of HER2. The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test which shows promise in measuring HER2 expression (extracellular domain) for the entire disease burden and which could identify non responding patients prior to TDM1 administration. Rationale II: As for many such agents, it is desirable to identify early on (here with the use of FDG-PET/CT) which patients are unlikely to benefit from the therapy
Sponsor: Jules Bordet Institute
Intervention: T-DM1, 89Zr-trastuzumab
Start Date: May 2012
Last Updated: August 14, 2023
Number of Patients: 90
Recruitment Status: Active, not recruiting
Condition: HER-2 Positive Breast Cancer

NCTID: NCT04109131

Title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
Study Summary: Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.
Sponsor: Jules Bordet Institute
Intervention: Samples collection: Plasma, Samples collection: CSF, Samples collection: Non-CNS Metastatic Tumour Tissue, Brain MRI, Samples collection: Serum
Start Date: July 1, 2020
Last Updated: March 28, 2023
Number of Patients: 600
Recruitment Status: Recruiting
Condition: CNS Metastases

NCTID: NCT01932489

Title: THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility
Study Summary: Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing. Results will be discussed during a molecular screening tumor board.
Sponsor: Jules Bordet Institute
Intervention: Biopsy of a metastatic lesion.
Start Date: December 2013
Last Updated: May 23, 2018
Number of Patients: 35
Recruitment Status: Completed
Condition: Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma

NCTID: NCT04613765

Title: A Mixed Method Study Design to Explore Adherence of Haematological Cancer Patients to Oral Anticancer Medication in a Multilingual and Multicultural Outpatient Setting: the MADESIO Protocol
Study Summary: Patients with haematologic malignancies are increasingly treated by Oral Anticancer Medications (OAMs), increasing the challenge of ensuring optimal adherence to treatment. However, except for Chronic Myelogenous Leukemia (CML) or Acute Lymphoid Leukemia (ALL), the extent of non-adherence has rarely been investigated in an outpatient setting. In Belgium, the only available data suffers from critical underrepresentation of patients from minority diverse population. In the context of increasing migration, the identification of differences in access and drug use that may lead to health disparities is crucial. Based on a sequential mixed method study design, our objectives are to measure adherence to OAMs in two subgroups of non-migrants and migrants with various haematological malignancies, to identify the associated risk factors and to explore the representations that come into play with regards to illness and adherence behaviors. Essentially, the MADESIO protocol will contribute to assess whether and why patients with migrant backgrounds are a risk group regarding adherence to OAMs.
Sponsor: Jules Bordet Institute
Intervention: Measure adherence behaviors
Start Date: December 1, 2020
Last Updated: November 3, 2020
Number of Patients: 113
Recruitment Status: Unknown status
Condition: Adults, Hematological Malignancy, Oral Antineoplastic Agents

NCTID: NCT00199160

Title: character(0)
Study Summary: This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.
Sponsor: Jules Bordet Institute
Intervention: BAY 43-9006
Start Date: April 2005
Last Updated: May 20, 2015
Number of Patients: 60
Recruitment Status: Completed
Condition: Head and Neck Neoplasms

NCTID: NCT06107608

Title: Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
Study Summary: Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease.
Sponsor: Jules Bordet Institute
Intervention: FAPI PET/CT
Start Date: June 13, 2023
Last Updated: October 30, 2023
Number of Patients: 58
Recruitment Status: Recruiting
Condition: Non Small Cell Lung Cancer

NCTID: NCT01301040

Title: Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.)
Study Summary: The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT. This study also will compare the serum biomarkers profile during and after the (neo) adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess whether brain PET-CT allows detecting regional functional impairment in patients receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate psychological state and burden of primary caregivers before and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the Framingham risk score for Hard Coronary Heart Disease (10-year risk).
Sponsor: Jules Bordet Institute
Intervention: epirubicin, cyclophosphamide, docetaxel
Start Date: March 2011
Last Updated: August 30, 2013
Number of Patients: 2
Recruitment Status: Terminated
Condition: Breast Cancer

NCTID: NCT06059469

Title: PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer
Study Summary: This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.
Sponsor: Jules Bordet Institute
Intervention: Ga-PSMA PET/CT
Start Date: May 30, 2022
Last Updated: September 28, 2023
Number of Patients: 20
Recruitment Status: Recruiting
Condition: TNBC - Triple-Negative Breast Cancer

NCTID: NCT01860742

Title: Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b
Study Summary: The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant to therapy with somatostatin analogues, in terms of disease control.
Sponsor: Jules Bordet Institute
Intervention: Interferon alpha-2b, 177Lu-DOTATATE
Start Date: December 2014
Last Updated: April 5, 2016
Number of Patients: 0
Recruitment Status: Withdrawn
Condition: Gastro-intestinal Neuroendocrine Tumors

NCTID: NCT00199212

Title: A Phase I, Open Label, Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin, in Patients With Advanced Breast Cancer That Overexpresses HER-2
Study Summary: The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.
Sponsor: Jules Bordet Institute
Intervention: Combination of trastuzumab and PS-341
Start Date: October 2003
Last Updated: February 24, 2011
Number of Patients: 19
Recruitment Status: Completed
Condition: Carcinoma Breast Stage IV

NCTID: NCT05429866

Title: Immunological Variables Associated to ICI Toxicity in Cancer Patients
Study Summary: This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy. For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points: Early (4-6 weeks after treatment start) Midtime (8-11 weeks after treatment start) Late (13-18 weeks after treatment start) At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points: For the 1st time of any grade 1 or 2 irAE if the subject developed it. For the 1st time of any grade 3 or 4 irAE if the subject developed it.
Sponsor: Jules Bordet Institute
Intervention: Checkpoint Blockade, Immune
Start Date: September 1, 2022
Last Updated: March 8, 2023
Number of Patients: 441
Recruitment Status: Recruiting
Condition: Breast Cancer, Melanoma, Non Small Cell Lung Cancer, Non-melanoma Skin Cancer, Gastrointestinal Cancer, Head and Neck Cancer, Renal Cell Carcinoma, Small Cell Lung Cancer, Mesothelioma, Malignant, Bladder Cancer, Merkel Cell Carcinoma, Hepatocellular Carcinoma, MSI-H Colorectal Cancer

NCTID: NCT02338531

Title: Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer
Study Summary: This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy.
Sponsor: Jules Bordet Institute
Intervention: PF-03084014, Breast cancer surgery
Start Date: June 2015
Last Updated: April 29, 2016
Number of Patients: 0
Recruitment Status: Withdrawn
Condition: Breast Cancer

NCTID: NCT05502224

Title: Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
Study Summary: Prospective longitudinal, single-center, non-randomized study for the implementation of an integrated multidisciplinary fatigue follow-up for young patients with breast cancer or germ cell tumour
Sponsor: Jules Bordet Institute
Intervention: Ergospirometry
Start Date: August 19, 2022
Last Updated: November 8, 2022
Number of Patients: 50
Recruitment Status: Recruiting
Condition: Breast Cancer, Germ Cell Tumor

NCTID: NCT00162812

Title: Prospective Evaluation of Topoisomerase II Alpha Gene Amplification and Protein Overexpression as Markers Predicting the Efficacy of Epirubicin in the Primary Treatment of Breast Cancer Patients
Study Summary: prospective evaluation of topoisomerase II alpha gene amplification and protein overexpression as markers predicting the efficacy of epirubicin in the primary treatment of breast cancer patients.
Sponsor: Jules Bordet Institute
Intervention: Epirubicin
Start Date: January 2003
Last Updated: July 18, 2008
Number of Patients: 338
Recruitment Status: Terminated
Condition: Breast Cancer

NCTID: NCT05075538

Title: COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2
Study Summary: This trial aims to measure the humoral and adaptive immune response in patients with cancer diagnosis undergoing mRNA vaccination against SARS-CoV-2 and assess its efficacy in preventing COVID-19.
Sponsor: Jules Bordet Institute
Intervention: Spikevax, Comirnaty, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4-5
Start Date: December 1, 2021
Last Updated: February 27, 2023
Number of Patients: 440
Recruitment Status: Recruiting
Condition: Cancer

NCTID: NCT01993576

Title: Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection
Study Summary: The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.
Sponsor: Jules Bordet Institute
Intervention: Indocyanine Green
Start Date: January 2013
Last Updated: October 15, 2014
Number of Patients: 10
Recruitment Status: Completed
Condition: Breast Cancer.

NCTID: NCT00263705

Title: Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study
Study Summary: Determination of guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population of Patients over 70 years old.
Sponsor: Jules Bordet Institute
Intervention: Adjuvant capecitabine, capecitabine in aduvant setting
Start Date: January 2003
Last Updated: February 24, 2011
Number of Patients: 43
Recruitment Status: Completed
Condition: Elderly Patients, Breast Cancer

NCTID: NCT02027831

Title: Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)
Study Summary: The purpose of this study is to determine if NIR fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour
Sponsor: Jules Bordet Institute
Intervention: Indocyanine Green
Start Date: December 2013
Last Updated: July 24, 2014
Number of Patients: 10
Recruitment Status: Unknown status
Condition: Head and Neck Cancer

NCTID: NCT00741481

Title: Evaluation of Prognostic and Predictive Value of PETSCAn in ColoRectal Cancer (CRC)
Study Summary: Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy. FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in metastatic colorectal cancer. SUV max will be recorded and delta SUVmax will be compared to the results of conventional radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the time to disease progression.
Sponsor: Jules Bordet Institute
Intervention: FDG-PET imaging
Start Date: June 2006
Last Updated: February 24, 2011
Number of Patients: 40
Recruitment Status: Completed
Condition: Colorectal Cancer Metastatic, Early Response Evaluation, Fdg-PET

NCTID: NCT02032563

Title: Study of the (Intravenously Injected) Indocyanine Green Distribution in Tumour Bearing Breasts and in Axillary Pieces of Dissection of Patients Who Have Received Neoadjuvant Therapy for Histologically Proven Mammary Cancer
Study Summary: We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)
Sponsor: Jules Bordet Institute
Intervention: Indocyanine Green
Start Date: December 2013
Last Updated: July 24, 2014
Number of Patients: 20
Recruitment Status: Unknown status
Condition: Breast Cancer

NCTID: NCT00614978

Title: Phase 1 Study of the Combination of Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer
Study Summary: Objectives: Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR), Clinical Benefit (CB) and Duration of Response (DR) Methodology: Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after surgery or radiotherapy or radiosurgery Treatment: Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in increments according to the dose escalation scheme, and determined by dose limiting toxicities.
Sponsor: Jules Bordet Institute
Intervention: lapatinib and temozolomide
Start Date: January 2008
Last Updated: September 19, 2012
Number of Patients: 18
Recruitment Status: Completed
Condition: Metastatic Breast Cancer, Brain Metastases, HER2 Positive

NCTID: NCT00199173

Title: Comparison Hepatic Intra-arterial Injection of Yttrium-90 Versus 5FU in Colorectal Cancer Metastatic to the Liver Only
Study Summary: This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation [SIR] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.
Sponsor: Jules Bordet Institute
Intervention: SIR Spheres intra-arterial hepatic
Start Date: character(0)
Last Updated: February 24, 2011
Number of Patients: character(0)
Recruitment Status: Completed
Condition: Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver

NCTID: NCT01913067

Title: A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer
Study Summary: A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC). OBJECTIVES: Primary: The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation. Secondary: To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery To determine the effect of cabazitaxel on the time to developing neurological symptoms To determine the effect of cabazitaxel on the time to disease progression in the brain To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts To determine the safety of cabazitaxel
Sponsor: Jules Bordet Institute
Intervention: Cabazitaxel, Contrast-enhanced whole brain MRI
Start Date: September 2013
Last Updated: July 24, 2014
Number of Patients: 0
Recruitment Status: Withdrawn
Condition: Brain Metastasis, Breast Cancer, Non Small Cell Lung Cancer

NCTID: NCT06061874

Title: Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Study Summary: This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein). The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.
Sponsor: Jules Bordet Institute
Intervention: FAPI PET/CT
Start Date: May 30, 2023
Last Updated: September 29, 2023
Number of Patients: 80
Recruitment Status: Recruiting
Condition: Cancer, Peritoneal Carcinomatosis

NCTID: NCT01995591

Title: Prospective Open-label Study Using ex Vivo Injection of ICG to Detect SLN in Patients With Colon Cancer
Study Summary: Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.
Sponsor: Jules Bordet Institute
Intervention: character(0)
Start Date: January 2013
Last Updated: January 12, 2016
Number of Patients: 20
Recruitment Status: Completed
Condition: Colon Cancer, Colon Surgery

NCTID: NCT01843725

Title: Modulation of Metabolic Index in Tailoring Treatment of Incurable Metastatic ColoRectal Cancer (CRC) Program 1
Study Summary: Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with Aflibercept.
Sponsor: Jules Bordet Institute
Intervention: capecitabine, aflibercept, Capecitabine
Start Date: September 2013
Last Updated: January 31, 2018
Number of Patients: 37
Recruitment Status: Completed
Condition: Metastatic Colorectal Cancers, Metastatic Gastric Cancers, Metastatic Oesophageal Cancers, Metastatic Pancreatic Cancers, Metastatic Biliary Cancers, Metastatic Breast Cancers

NCTID: NCT01591590

Title: Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer
Study Summary: The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
Sponsor: Jules Bordet Institute
Intervention: FDG PET-CT, Diffusion MRI, Blood samples (plasma preparation and CTC)
Start Date: June 2012
Last Updated: October 26, 2021
Number of Patients: 53
Recruitment Status: Completed
Condition: Colorectal Cancer

NCTID: NCT02836197

Title: Communication About Uncertainty and Hope: A Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program for Physicians Caring for Cancer Patients
Study Summary: Background: Although previous studies have reported the efficacy of communication skills training programs (CST), specific training addressing communication about uncertainty and hope in oncology has not yet been studied. This paper describes the study protocol of a randomized controlled trial assessing the efficacy of a CST program aimed at improving physician ability to communicate about uncertainty and hope in encounters with cancer patients. Methods: Physician participants will be randomly assigned in groups (n = 3/group) to a 30-hour CST program (experimental group) or to a waiting list (control group). The training program will include learner-centered, skills-focused, practice-oriented techniques. Training efficacy is assessed in the context of an encounter with a simulated advanced stage cancer patient at baseline and after the CST for the experimental group, and after four months for the waiting-list group. Efficacy assessments will include communicational, psychological and physiological measures. Group-by-time effects will be analyzed using a generalized estimating equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30 control) participants will be sufficient to detect effects. Discussion: The current study will aid in the development of effective CST programs to improve physician ability to communicate about uncertainty and hope in encounters with cancer patients.
Sponsor: Jules Bordet Institute
Intervention: Communication skills training
Start Date: August 2016
Last Updated: June 28, 2017
Number of Patients: 72
Recruitment Status: Unknown status
Condition: Physician Patient Relationship

NCTID: NCT01554943

Title: Late Cardiac Evaluation of the Three Arm Belgian Trial A Phase III Randomized Trial Involving Node-positive Early Breast Cancer Patients With a Long Median Follow-up (~ 15 Years)
Study Summary: Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (~ 15 years) OBJECTIFS Primary: • To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial Secondary: To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients; To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for: left ventricular diastolic function assessed by Echo exercise capacity assessed by 6-minute walk test (6MWT) cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI serum cardiac biomarkers (BNP and TNT) patient-reported cardiac symptoms patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment cognitive function, functional autonomy, and psychological distress
Sponsor: Jules Bordet Institute
Intervention: cardiac MRI
Start Date: July 2010
Last Updated: August 30, 2013
Number of Patients: 73
Recruitment Status: Completed
Condition: Breast Cancer

NCTID: NCT04019548

Title: Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy
Study Summary: Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer. Study is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement. All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
Sponsor: Jules Bordet Institute
Intervention: Percutaneous Endoscopic Gastrotomy tube placement, Cisplatin injection, Radiotherapy
Start Date: December 16, 2019
Last Updated: May 10, 2023
Number of Patients: 110
Recruitment Status: Recruiting
Condition: Oropharyngeal Cancer

NCTID: NCT05426330

Title: Cross-sectional, Observational Study of Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)
Study Summary: Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP. The primary objective of the project is to conduct a cross-sectional, observational study of the willingness of advanced cancer patients and their primary caregivers to communicate about ACP with each other and with the physician(s); and their agreement/disagreement with these respective willingness. The secondary objective of the project is to assess the medical, psychological and relational factors associated with these willingness. This study will involve 300 consecutive patient- primary caregiver-physician(s) triads. For each patient and their primary caregiver, an in-depth assessment of their willingness to communicate about ACP with each other and with the physician(s) will be conducted using specific scales. The medical, psychological and relational characteristics of the included patients and their primary caregiver will also be assessed using validated questionnaires. Results of this study will enable to propose innovative interventions likely to optimize the establishment of an ACP for numerous advanced cancer patients.
Sponsor: Jules Bordet Institute
Intervention: character(0)
Start Date: October 4, 2021
Last Updated: June 22, 2022
Number of Patients: 600
Recruitment Status: Recruiting
Condition: Advanced Cancer

NCTID: NCT04831905

Title: Etude de faisabilité de de tolérance d'un Traitement Focal Transrectal Par Micro-ondes de la Tumeur Index Des Patients Ayant un Cancer de la Prostate - FOSTINE 1b
Study Summary: With the advent of multiparametric MRI (mpMRI), the concept of focal therapy continues to develop as a compromise between active surveillance and radical tratment. However, it must be combined with the most stringent quality control measures, such as exceptional Imaging, to allow close management of the index tumor. the choice of the energy is also crucial. Several have been tested such as HIFU, electroporation or cryotherapy. A new therapeutic alternative currently Under investigation resides in the use of microwaves delivered through a thin needle inserted precisely into the index lesion according to the same procedure as targeted biopsy under image fusion to induce coagulation necrosis and lead to the tumor destruction. Through an ablate, performed transrectally under real-time MRI/TRUS image registration and 3D mapping, in patients with localized prostate cancer (PCa).
Sponsor: Jules Bordet Institute
Intervention: Micro-wave ablation
Start Date: March 1, 2021
Last Updated: April 5, 2021
Number of Patients: 10
Recruitment Status: Unknown status
Condition: Focal Treatment for Prostate Cancer

NCTID: NCT01537536

Title: An Open-label Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in Patients With HER2-negative Breast Cancer
Study Summary: The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).
Sponsor: Jules Bordet Institute
Intervention: EndoTAG-1
Start Date: November 2011
Last Updated: June 17, 2013
Number of Patients: 18
Recruitment Status: Completed
Condition: Breast Cancer

NCTID: NCT02032485

Title: Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Colorectal Cancer
Study Summary: The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients.
Sponsor: Jules Bordet Institute
Intervention: Indocyanine Green
Start Date: March 2013
Last Updated: October 15, 2014
Number of Patients: 10
Recruitment Status: Completed
Condition: Colorectal Cancer, Peritoneal Carcinomatosis

NCTID: NCT01420146

Title: Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results
Study Summary: Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.
Sponsor: Jules Bordet Institute
Intervention: Zr89-trastuzumab
Start Date: August 2011
Last Updated: April 18, 2017
Number of Patients: 20
Recruitment Status: Completed
Condition: Breast Neoplasms, Secondary, HER2 Positive Carcinoma of Breast

NCTID: NCT02027818

Title: Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy
Study Summary: We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent
Sponsor: Jules Bordet Institute
Intervention: Indocyanine Green
Start Date: January 2014
Last Updated: October 15, 2014
Number of Patients: 20
Recruitment Status: Completed
Condition: Breast Cancer

NCTID: NCT01513109

Title: A Phase I/II Study to Assess the Safety and Immunogenicity of WT1-A10 plus AS01B Antigen-Specific Cancer Immunotherapeutic (ASCI) Combined With Infusions of ex Vivo Regulatory T Cells Depleted T Lymphocytes in Vivo Regulatory T Cells Depleted Patients as Post-consolidation Therapy for Adult Patients With WT1-positive Acute Myeloid Leukemia (AML) in CR1 (for High Risk Patients) or in CR2 or CR3 Who Are Not Eligible for Allogeneic Stem Cell Transplantation (SCT)
Study Summary: The purpose of this study is to evaluate the safety and the efficacy of combined treatment strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in vivo regulatory T cells depletion as post-consolidation therapy in patients with WT1-positive Acute Myeloid Leukemia. The study will also evaluate the clinical activity and immune response of this approach in bad risk patients in CR1 and all patients in CR2 or CR3, non eligible for an allogeneic Hematopoietic Stem Cell Transplantation
Sponsor: Jules Bordet Institute
Intervention: Recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI)
Start Date: December 2011
Last Updated: January 20, 2012
Number of Patients: 20
Recruitment Status: Unknown status
Condition: Acute Myelogenous Leukemia, Myeloid Leukemia in Remission, Effects of Immunotherapy

NCTID: NCT03