Phase 3 Study Comparing FOLFIRI With or Without Bevacizumab to Irinotecan With or Without Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of FOLFIRI chemotherapy with or without Bevacizumab compared to Irinotecan CPT-11 with or without Bevacizumab as a second-line treatment for patients with metastatic colorectal cancer. This Phase III study aims to determine whether overall survival with FOLFIRI is not worse than with Irinotecan. Key goals include assessing progression-free survival, overall survival, time to treatment failure, response rates, disease control, and safety. The study involves two experimental treatment groups. One group receives Bevacizumab intravenously on day 1 of a two-week cycle, combined with CPT-11, l-LV or dl-LV, and 5-FU given as both a bolus and continuous infusion over 46 hours. The other group receives Bevacizumab with CPT-11 only, also on day 1 of a two-week cycle. These infusions are repeated every two weeks during the treatment period. Participants will undergo regular monitoring including assessments of tumor progression and response at scheduled intervals, laboratory tests to check organ function, and recording of any adverse events up to 24 weeks. The primary outcome, progression-free survival, is tracked until 1.5 years after the last patient is enrolled. Secondary outcomes such as overall survival and time to treatment failure are also measured during this period. This study requires informed consent and includes safety follow-up to ensure participant well-being throughout the trial.

A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC