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This is a multicentric study. All patients with TET (thymic epithelial tumors) of any histological type will participate in the study. This is an open-label phase 2 study that will follow a Green-Dahlberg 2-stage design whose objective is to evaluate the activity and safety of the combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with relapsed and / or metastatic thymic carcinoma/ thymoma B3, in the first line (RELEVENT trial).
Clinical and quality of life data will be collected for all treated patient. Based on the histological evaluation performed by each participating center, patients will be screened for inclusion in one of the three studies, based on the following criteria:
- TOPS studies only: all patients with A, AB, B1, B2, B3 without areas of carcinoma histology that do not have a fresh tissue sample and screen failures of the RELEVENT and BIOTET study;
- BIOTET only: all patients with A, AB, B1, B2, B3 without areas of histology of the carcinoma that have a fresh tissue sample;
- RELEVENT only: all patients with thymoma B3 and areas of carcinoma and patients with thymic carcinoma who do not have a fresh tissue sample;
- RELEVENT and BIOTET: all patients with thymoma B3 and areas of carcinoma and patients with thymic carcinoma who meet the inclusion / exclusion criteria and for whom a fresh tissue sample is available.Finally, the RELEVENT and BIOTET study patients will continue the observational follow-up of the TOPS study, once the clinical and biological study procedures have been completed.
All patients, regardless of histological status, will be invited to participate in the clinical follow up observational and collection of PROMIS 29 in scope of the prospective TET study (TOPS).
Patients with thymic carcinoma or thymoma B3 with areas of carcinoma will receive a centralized pathological review of the tumour block or slides and will be screened to participate in the Phase II RELEVENT pharmacological study.Histological diagnosis will be confirmed before screening.
Fondazione IRCCS Istituto Nazionale dei Tumori
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Published on BioPortfolio: 2019-04-25T15:24:33-0400
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