Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study

Colorectal Carcinomatosis Clinical Trial

Official title:

Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis - French Part of the Main Bev-IP Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03161041
• Other study ID #: 69HCL17_0239
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 21, 2018
• Est. completion date: November 13, 2018

Study information

• Verified date: November 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinomatosis

Intervention

Procedure:
• Cytoreductive surgery combined with HIPEC
Procedure/Surgery: Cytoreductive surgery combined with HIPEC (Oxaliplatin 360 mg/m2).

Drug:
• bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).
bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification	Major morbidity (grade IIIb or higher grade complication according to Dindo-Clavien classification)	Until 3 months after surgery and intraperitoneal chemotherapy
Secondary	Number of participants with treatement related Adverse events less than grade IIIb as assessed by Dindo-Clavien classification	Minor morbidity (less than grade IIIb complication according to Dindo-Clavien classification).	Until 3 months after surgery and intraperitoneal chemotherapy
Secondary	Potential chemotherapy related morbidity	Adverse events will be described using MedDRA terms (version 18.0) and graded according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)	During the first 60 postoperative days
Secondary	Overall survival	calculated from date of surgery until death	24 months after finishing the adjuvant chemotherapy
Secondary	Progression free survival	Time interval between date of surgery and disease progression or death	24 months after finishing the adjuvant chemotherapy
Secondary	Pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab	Scored with a 3 level regression scale	Day 1 after termination of the cytoreductive surgery
Secondary	Quality of life assessment	Using the EORTC QLQ-C30 questionnaires	24 months after finishing the adjuvant chemotherapy
Secondary	Treatment completion rate	Percentage of patients receiving all planned courses	Day 1 after termination of adjuvant chemotherapy
Secondary	Quality of life assessment	Using SF 36 questionnaires	24 months after finishing the adjuvant chemotherapy