Clinical trial NCT02399410: Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis
Official title: BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: cytoreductive surgery
hipec
perioperative chemotherapy
peritoneal carcinomatosis
bevacizumab
colorectal surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: surgical morbidity and mortality
timeFrame: until 3 months after surgery and intraperitoneal chemotherapy
Secondary outcomes:
measure: progression free survival
timeFrame: 24 months after finishing the adjuvant chemotherapy
measure: overall survival
timeFrame: 24 months after finishing the adjuvant chemotherapy
measure: treatment completion rate
timeFrame: day 1 after termination of adjuvant chemotherapy
measure: chemotherapy-related toxicity
timeFrame: 1 month after termination of the adjuvant chemotherapy
measure: pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab
timeFrame: day 1 after termination of the cytoreductive surgery
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Wim P Ceelen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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