NCT02399410CompletedPhase 2
BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis
University Hospital, Ghent1 site in 1 country60 target enrollmentStarted: November 4, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- surgical morbidity and mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 inclusion in other clinical trials interfering with the study protocol
- •No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Absence of heart failure (NYHA 2 or > 2) or significant coronary artery disease
- •No pregnancy or breast feeding
- •Adequate contraception in fertile patients
Exclusion Criteria
- •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
Arms & Interventions
bevacizumab and CRS with oxaliplatin
Experimental
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Intervention: perioperative chemotherapy plus bevacizumab (Drug)
bevacizumab and CRS with oxaliplatin
Experimental
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Intervention: cytoreductive surgery (Procedure)
bevacizumab and CRS with oxaliplatin
Experimental
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Intervention: Intraperitoneal Oxaliplatin (Drug)
Outcomes
Primary Outcomes
surgical morbidity and mortality
Time Frame: until 3 months after surgery and intraperitoneal chemotherapy
This will be estimated with the Dindo-Clavien classification
Secondary Outcomes
- progression free survival(24 months after finishing the adjuvant chemotherapy)
- treatment completion rate(day 1 after termination of adjuvant chemotherapy)
- overall survival(24 months after finishing the 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)
Investigators
Study Sites (1)
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