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

Primary Purpose

Colorectal Carcinomatosis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cytoreductive surgery combined with HIPEC

bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

About this trial

This is an interventional treatment trial for Colorectal Carcinomatosis focused on measuring Cytoreductive surgery, HIPEC, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab and CRS with oxaliplatin

Arm Description

Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).

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)

Overall survival

calculated from date of surgery until death

Progression free survival

Time interval between date of surgery and disease progression or death

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

Scored with a 3 level regression scale

Quality of life assessment

Using the EORTC QLQ-C30 questionnaires

Treatment completion rate

Percentage of patients receiving all planned courses

Quality of life assessment

Using SF 36 questionnaires

Full Information

NCT ID

NCT03161041

First Posted

May 18, 2017

Last Updated

November 13, 2018

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT03161041

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Withdrawn

Why Stopped

CHU Lyon will join as a participating center (and as national French coordinator) as a part of the BEV-IP study ongoing study EudraCT-number 2014-004257-14.

Study Start Date

September 21, 2018 (Actual)

Primary Completion Date

November 13, 2018 (Anticipated)

Study Completion Date

November 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Carcinomatosis

Keywords

Cytoreductive surgery, HIPEC, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab and CRS with oxaliplatin

Arm Type

Experimental

Arm Description

Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

Intervention Type

Procedure

Intervention Name(s)

Cytoreductive surgery combined with HIPEC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

Intervention Description

bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

Primary Outcome Measure Information:

Title

Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification

Description

Major morbidity (grade IIIb or higher grade complication according to Dindo-Clavien classification)

Time Frame

Until 3 months after surgery and intraperitoneal chemotherapy

Secondary Outcome Measure Information:

Title

Number of participants with treatement related Adverse events less than grade IIIb as assessed by Dindo-Clavien classification

Description

Minor morbidity (less than grade IIIb complication according to Dindo-Clavien classification).

Time Frame

Until 3 months after surgery and intraperitoneal chemotherapy

Title

Potential chemotherapy related morbidity

Description

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)

Time Frame

During the first 60 postoperative days

Title

Overall survival

Description

calculated from date of surgery until death

Time Frame

24 months after finishing the adjuvant chemotherapy

Title

Progression free survival

Description

Time interval between date of surgery and disease progression or death

Time Frame

24 months after finishing the adjuvant chemotherapy

Title

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

Description

Scored with a 3 level regression scale

Time Frame

Day 1 after termination of the cytoreductive surgery

Title

Quality of life assessment

Description

Using the EORTC QLQ-C30 questionnaires

Time Frame

24 months after finishing the adjuvant chemotherapy

Title

Treatment completion rate

Description

Percentage of patients receiving all planned courses

Time Frame

Day 1 after termination of adjuvant chemotherapy

Title

Quality of life assessment

Description

Using SF 36 questionnaires

Time Frame

24 months after finishing the adjuvant chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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