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

NCT03161041 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-11-14

No results posted yet for this study

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.

Conditions

  • Colorectal Carcinomatosis

Interventions

PROCEDURE

Cytoreductive surgery combined with HIPEC

Procedure/Surgery: Cytoreductive surgery combined with HIPEC (Oxaliplatin 360 mg/m2).

DRUG

bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161041 on ClinicalTrials.gov