Clinical trial NCT03161041: Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study
Official title: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis - French Part of the Main Bev-IP Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Colorectal Carcinomatosis
Keywords: Cytoreductive surgery, HIPEC, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 m2
* 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: Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification
timeFrame: Until 3 months after surgery and intraperitoneal chemotherapy
Secondary outcomes:
measure: Number of participants with treatement related Adverse events less than grade IIIb as assessed by Dindo-Clavien classification
timeFrame: Until 3 months after surgery and intraperitoneal chemotherapy
measure: Potential chemotherapy related morbidity
timeFrame: During the first 60 postoperative days
measure: Overall survival
timeFrame: 24 months after finishing the adjuvant chemotherapy
measure: Progression free survival
timeFrame: 24 months after finishing 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
measure: Quality of life assessment
timeFrame: 24 months after finishing the adjuvant chemotherapy
measure: Treatment completion rate
timeFrame: Day 1 after termination of adjuvant chemotherapy
measure: Quality of life assessment
timeFrame: 24 months after finishing the adjuvant chemotherapy
Other outcomes:
Locations:
Study officials:
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