drugset / Trial / NCT03161041

Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study

NCT03161041 ↗

Phase 2 Withdrawn Hospices Civils de Lyon
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-09-21
Primary completion
2018-11-13
Completion
2018-11-13

Outcome

Outcome not reported

Stopped: “CHU Lyon will join as a participating center (and as national French coordinator) as a part of the BEV-IP study ongoing study EudraCT-number 2014-004257-14.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — —
Subject Oxaliplatin Small molecule 360 mg/m2 Other