Editing Trials (Masaryk Memorial Cancer Institute)

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'''NCTID''': NCT05603351
 '''Title''': Prostate Cancer Screening With Abbreviated MRI Protocol
 '''Study Summary''': Prostate cancer is one of the most common malignancies in the male population with incidence and mortality rates comparable to breast cancer in women, but in contrast, a population screening program that would fulfill all the recommended criteria is not yet available. According to international recommendations, the preventive PSA sampling used in clinical practice is not suitable because of the concurrent detection of clinically insignificant carcinomas in a major proportion of tests. These clinically non-significant cancers make up a significant and increasing proportion with age. Detection of non-significant cancers burdens the health care system and patients with the care that has no positive impact on their health. Current preventive serum prostate-specific antigen (PSA) testing does not distinguish benign hyperplasia and nonsignificant carcinoma from clinically significant cancer. It is therefore not suitable for full-scale screening  According to current guidelines, magnetic resonance imaging (MRI) is indicated only in patients with an increased risk of cancer for detection or staging after biopsy and is not used for screening. According to recent studies, MRI has detected an increased proportion of significant cancers in the general population compared to screening based on PSA, while fewer clinically insignificant cancers have been detected. In screening, a shorter examination protocol without contrast medium (biparametric MRI) is used with a lower cost per examination, allowing to increase both the number of patients examined and patient comfort  The main objective of the project is to assess the contribution of imaging in the screening of clinically significant prostate cancer and to validate the published results in the Czech population, and extend the screening model by the second round of examinations and additional laboratory markers. The secondary aim is to design a subsequent study with a larger number of participants allowing statistical evaluation, similar to the successful breast cancer screening.
 '''Sponsor''': Masaryk Memorial Cancer Institute
 '''Intervention''': magnetic resonance
 '''Start Date''': 2022-05-01
 '''Last Updated''': 2022-11-02
 '''Number of Patients''': 300
 '''Recruitment Status''': RECRUITING
 '''Condition''': Prostate Cancer
'''NCTID''': NCT04580251
 '''Title''': Ideal Marker for Targeted Axillary Dissection
 '''Study Summary''': A multicentre prospective comparative study, comparing the use of various markers (magnetic marker Magseed, iodine seed 125I, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.
 '''Sponsor''': University Hospital Ostrava
 '''Intervention''': Targeted axillary dissection
 '''Start Date''': 2021-01-01
 '''Last Updated''': 2023-09-07
 '''Number of Patients''': 100
 '''Recruitment Status''': COMPLETED
 '''Condition''': Breast Cancer
'''NCTID''': NCT05348486
 '''Title''': FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
 '''Study Summary''': Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.
 '''Sponsor''': University Hospital Olomouc
 '''Intervention''': Dose escalation
 '''Start Date''': 2022-04-20
 '''Last Updated''': 2022-05-11
 '''Number of Patients''': 120
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Head and Neck Cancer
'''NCTID''': NCT03443856
 '''Title''': Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence
 '''Study Summary''': The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection  Other study objectives  * To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the stud * To correlate nutritional status assessment on outcomes and quality of life of patients
 '''Sponsor''': European Organisation for Research and Treatment of Cancer - EORTC
 '''Intervention''': Nivolumab and Ipilimumab
 '''Start Date''': 2019-07-17
 '''Last Updated''': 2023-09-07
 '''Number of Patients''': 197
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Gastric and Esophagogastric Junction Adenocarcinoma
'''NCTID''': NCT04031677
 '''Title''': Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
 '''Study Summary''': This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival  After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
 '''Sponsor''': European Organisation for Research and Treatment of Cancer - EORTC
 '''Intervention''': Surgery
 '''Start Date''': 2021-01-20
 '''Last Updated''': 2023-10-27
 '''Number of Patients''': 250
 '''Recruitment Status''': RECRUITING
 '''Condition''': Retroperitoneal Sarcoma
'''NCTID''': NCT04921553
 '''Title''': Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
 '''Study Summary''': This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion  This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications.
 '''Sponsor''': Centre Leon Berard
 '''Intervention''': Data collection and quality of life questionnaire
 '''Start Date''': 2021-06-22
 '''Last Updated''': 2021-08-02
 '''Number of Patients''': 500
 '''Recruitment Status''': RECRUITING
 '''Condition''': Cancer
'''NCTID''': NCT00388726
 '''Title''': E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer
 '''Study Summary''': The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.
 '''Sponsor''': Eisai Inc.
 '''Intervention''': E7389
 '''Start Date''': 2006-11
 '''Last Updated''': 2020-01-07
 '''Number of Patients''': 762
 '''Recruitment Status''': COMPLETED
 '''Condition''': Breast Cancer/