BEV-IP: Perioperative chemotherapy with bevacizumab in patients undergoing cytoreduction and intraperitoneal chemoperfusion for colorectal carcinomatosis

BMC Cancer. 2015 Dec 16;15:980. doi: 10.1186/s12885-015-1954-x.

Abstract

Background: 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.

Methods/design: 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.

Discussion: The BEV-IP trial is the first prospective assessment of the safety and efficacy of perioperative chemotherapy combined with anti-angiogenic treatment in patients undergoing CRS and IPC for colorectal peritoneal metastases.

Trial registration: ClinicalTrials.gov Identifier: NCT02399410 EudraCT number: 2015-001187-19 (registered March 9, 2015).

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Bevacizumab / administration & dosage*
  • Carcinoma / drug therapy*
  • Carcinoma / pathology
  • Carcinoma / surgery
  • Chemotherapy, Cancer, Regional Perfusion / methods*
  • Colorectal Neoplasms / drug therapy
  • Colorectal Neoplasms / pathology*
  • Colorectal Neoplasms / surgery
  • Combined Modality Therapy
  • Cytoreduction Surgical Procedures
  • Female
  • Humans
  • Male
  • Organoplatinum Compounds / administration & dosage
  • Oxaliplatin
  • Peritoneal Neoplasms / drug therapy*
  • Peritoneal Neoplasms / surgery
  • Research Design

Substances

  • Organoplatinum Compounds
  • Oxaliplatin
  • Bevacizumab

Associated data

  • EudraCT/EUDRACT2015-001187-19
  • ClinicalTrials.gov/NCT02399410