Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

NCT02399410 | Completed Phase 2 DMC

• 1 other identifier: EC/2014/1042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.

Conditions

Colorectal Neoplasms

Keywords

cytoreductive surgery; hipec; perioperative chemotherapy; peritoneal carcinomatosis; bevacizumab; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• surgical morbidity and mortality

  This will be estimated with the Dindo-Clavien classification

  until 3 months after surgery and intraperitoneal chemotherapy

Secondary Outcomes (5)

• progression free survival

  24 months after finishing the adjuvant chemotherapy

• overall survival

  24 months after finishing the adjuvant chemotherapy

• treatment completion rate

  day 1 after termination of adjuvant chemotherapy

• chemotherapy-related toxicity

  1 month after termination of the adjuvant chemotherapy

• pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab

  day 1 after termination of the cytoreductive surgery

Study Arms (1)

bevacizumab and CRS with oxaliplatin

EXPERIMENTAL

Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

Drug: perioperative chemotherapy plus bevacizumab; Procedure: cytoreductive surgery; Drug: Intraperitoneal Oxaliplatin

Interventions

perioperative chemotherapy plus bevacizumab DRUG

preoperative and postoperative combination chemotherapy with bevacizumab

bevacizumab and CRS with oxaliplatin

cytoreductive surgery PROCEDURE

complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.

bevacizumab and CRS with oxaliplatin

Intraperitoneal Oxaliplatin DRUG

Pump-driven intraperitoneal administration of oxaliplatin

bevacizumab and CRS with oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
• absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
• resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
• complete macroscopic cytoreduction at the time of surgery (CC-0/1)
• good general health status (Karnofsky index \> 70%)
• expected life expectancy more than 6 months
• no other malignancy than disease under study
• serum creatinine \< 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
• serum total bilirubin \< 1.5 mg/dl
• platelet count \> 100,000/ml
• hemoglobin \> 9g/dl
• neutrophil granulocytes \> 1,500/ml
• International Normalized Ration (INR) 2 or \< 2
• Absence of alcohol and/or drug abuse
• No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol

You may not qualify if:

• No written informed consent
• tumour in the presence of obstruction
• evidence of extra-abdominal disease or extensive liver metastasis
• peritoneal cancer index \> 25
• active bacterial, viral or fungal infection
• active gastro-duodenal ulcer
• parenchymal liver disease (any stage cirrhosis)
• uncontrolled diabetes mellitus
• severe obstructive or restrictive respiratory insufficiency
• psychiatric pathology capable of affecting comprehension and judgment faculty
• Known allergy to oxaliplatin

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

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MeSH Terms

Conditions

Colorectal Neoplasms; Peritoneal Neoplasms

Interventions

Bevacizumab; Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Surgical Procedures, Operative

Study Officials

• Wim P Ceelen, MD,PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 26, 2015
• Study Start: November 4, 2015
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

BE (1)