Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients (NEXT-REGIRI)
|ClinicalTrials.gov Identifier: NCT03829462|
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer (mCRC)||Drug: Regorafenib Drug: Irinotecan||Phase 3|
A Phase III randomized trial that compared Nexiri (Nexavar® + Irinotecan) vs irinotecan or versus Sorafenib alone showed a progression-free survival at two-months which was favorable to the NEXIRI combination ; 59% ( IC95% : 39-66 ) versus 23% (IC95% : 10-33) and 22% (IC95%: 8-30) respectively.
The patients treated with Irinotecan or Sorafenib alone could receive NEXIRI combination after progression and the progression-free survivals were 3,7 months (IC95% : 2,2-4,9) and 3,5 months (IC95% : 2,1-3,7) in patients treated with NEXIRI or after progression and 1,9 months (IC95% : 1,7-2,1) and 2,1 months (IC95% : 1,9-2,5) in patients treated only with Irinotecan and Sorafenib respectively.
The median overall survival was higher with NEXIRI : 7,2 months (patients treated from the beginning of the study) and 7,9 months (patients treated after progression and crossover) versus 3 months in patients treated only with Irinotecan and 3,2 months in patients receiving only Sorafenib.
The A870A rs603965 polymorphism of cyclin D1, a molecule involved in the initiation of cell division, was favorable to the NEXIRI combination on overall survival with a median of 19.6 months versus 6.2 months for two other genotypes A/G and G/G.
Regorafenib, which is an oral signal deactivation agent with a chemical structure very similar to Sorafenib, is a standard treatment in heavily pretreated mCRC patients since the results of CORRECT study which compared Regorafenib to placebo on overall survival showed a superiority of Regorafenib : 6,4 months versus 5 months (HR 0,774 [IC95% 0,63, 0,94]).
Sorafenib isn't approved in mCRC so the objective of this NEXT-REGIRI trial is compared REGIRI combination (Regorafenib-Irinotecan) to Regorafenib alone in a phase III trial in patients in progression after having received all standard treatments and bearing genotype A/A of cyclin D1
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Irinotecan + regorafenib (REGIRI)
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
regorafenib tab 40 mg i.e 160 mg/day
irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
Active Comparator: regorafenib
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
regorafenib tab 40 mg i.e 160 mg/day
- Overall survival [ Time Frame: Approximately 36 months ]From randomization of first patient until the datebase cut-off
- Progression-free survival (PFS) [ Time Frame: Approximately 36 months ]From randomization of first patient until the datebase cut-off,
- Disease control rate (DCR) [ Time Frame: Tumor is assessed every 8 weeks ]From randomization of first patient until the datebase cut-off,
- Objective response rate (OOR) [ Time Frame: Tumor is assessed at 8 weeks intervals ]From randomization of first patient until the datebase cut-off,
- Assessment of adverse events by using the NCI-CTCAE version 5.0 scale [ Time Frame: Approximately 36 months ]From randomization of first patient until the end of treatment,
- Quality of life questionnaire [ Time Frame: questionnaire is assessed at 8 weeks intervals ]From date of randomization until the date of end of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829462
|Contact: Jean-Pierre BLEUSE, MD||0467613102 ext +email@example.com|
|CRLC Val d'Aurelle-Paul Lamarque||Recruiting|
|Montpellier, France, 34298|
|Contact: Emmanuelle SAMALIN, MD|
|Principal Investigator: Emmanuelle SAMALIN, MD|
|Study Chair:||Emmanuelle SAMALIN, MD||Institut régional du cancer de Montpellier|