Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study
- Sponsor
- Hospices Civils de Lyon
- Study ID
- NCT03161041
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Colorectal Carcinomatosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cytoreductive surgery combined with HIPEC — PROCEDUREProcedure/Surgery: Cytoreductive surgery combined with HIPEC (Oxaliplatin 360 mg/m2).
- bevacizumab and HIPEC (Oxaliplatin 360 mg/m2). — DRUGbevacizumab and HIPEC (Oxaliplatin 360 mg/m2).
Study Details
Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients. The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.
Key Dates
- First listed
- May 19, 2017
- Start date
- Sep 21, 2018
- Status verified
- Nov 2018
- Primary completion
- Nov 13, 2018
- Completion
- Nov 13, 2018
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bevacizumab and CRS with oxaliplatinPerioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Primary Outcome Measure
Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification [ Time Frame: Until 3 months after surgery and intraperitoneal chemotherapy ]