Ramucirumab and Carbo-Paclitaxel for Untreated Thymic Carcinoma / B3 Thymoma With Carcinoma (RELEVENT) (RELEVENT)
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|ClinicalTrials.gov Identifier: NCT03921671|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thymic Carcinoma Thymoma||Combination Product: Ramucirumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Green-Dahlberg 2-stage design|
|Masking:||None (Open Label)|
|Official Title:||Improving Treatment Strategies in Thymic Epithelial Tumors: a TYME Collaborative Effort|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||July 16, 2020|
|Estimated Study Completion Date :||July 16, 2022|
Experimental: Ramucirumab +carboplatin+ paclitaxel
All patient will receive the combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with recurrent and / or metastatic thymic carcinoma or thymoma B3 with area of carcinoma, in the first line.
Combination Product: Ramucirumab
Combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with carcinoma thymic (or thymoma B3 with areas of carcinoma), relapsed and / or metastatic, in the first line.
Other Name: CARBOPLATIN (AUC 5) + PACLITAXEL(200 mg / m2)
- Best tumour response (CR+PR) [ Time Frame: 6 months ]Objective tumor response will be assessed according to RECIST 1.1.
- Progression Free Survival (PFS) [ Time Frame: 4 years ]Disease progression will be established as the radiological progression according to RECIST 1.1 or through clinical assessment in case radiological evaluation is not feasible or as death from any cause due to clinical condition. PFS will be estimated through Kaplan-Meier method
- Overall Survival (OS) [ Time Frame: 4 years ]OS will be estimated through Kaplan-Meier method
- Comprehensive analysis of tumor mutational status on paraffin-embedded tissue [ Time Frame: 4 years ]Targeted re-sequencing of genes mutated in TETs in order to define the prognostic role of somatic mutations and their potential association to prognosis or response to therapy
- Comprehensive analysis of single nucleotide polymorphism in blood [ Time Frame: 4 years ]Genome-wide approach using a platform able to investigate more than 4 million SNP in order to find potential association with prognosis or response to therapy
- Analysis of circulating micro-RNA [ Time Frame: 4 years ]Analysis of micro-RNA in plasma and their evaluation as possible biomarker associated with prognosis or response to therapy
- Quality of life analysis through collection of Patients Reported Outcome (PROs) [ Time Frame: 4 years ]Web based PROs will be administered at each visit and data about compliance will be collected
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921671
|Contact: Lital Hollander,||02 3901 email@example.com|
|Contact: MARTINA IMBIMBO, MD||+39022390|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Recruiting|
|Contact: Miriam Fink +390223902757 firstname.lastname@example.org|
|Principal Investigator:||MARINA GARASSINO, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|