Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

Conditions

Colorectal Neoplasms

Keywords

cytoreductive surgery, hipec, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery

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.

Rovers KP, Bakkers C, Simkens GAAM, Burger JWA, Nienhuijs SW, Creemers GM, Thijs AMJ, Brandt-Kerkhof ARM, Madsen EVE, Ayez N, de Boer NL, van Meerten E, Tuynman JB, Kusters M, Sluiter NR, Verheul HMW, van der Vliet HJ, Wiezer MJ, Boerma D, Wassenaar ECE, Los M, Hunting CB, Aalbers AGJ, Kok NFM, Kuhlmann KFD, Boot H, Chalabi M, Kruijff S, Been LB, van Ginkel RJ, de Groot DJA, Fehrmann RSN, de Wilt JHW, Bremers AJA, de Reuver PR, Radema SA, Herbschleb KH, van Grevenstein WMU, Witkamp AJ, Koopman M, Haj Mohammad N, van Duyn EB, Mastboom WJB, Mekenkamp LJM, Nederend J, Lahaye MJ, Snaebjornsson P, Verhoef C, van Laarhoven HWM, Zwinderman AH, Bouma JM, Kranenburg O, van 't Erve I, Fijneman RJA, Dijkgraaf MGW, Hemmer PHJ, Punt CJA, Tanis PJ, de Hingh IHJT, Dutch Peritoneal Oncology Group (DPOG), Dutch Colorectal Cancer Group (DCCG).

2019-04-2581 citations

10.1186/s12885-019-5545-0

BEV-IP: Perioperative chemotherapy with bevacizumab in patients undergoing cytoreduction and intraperitoneal chemoperfusion for colorectal carcinomatosis.

Willaert W, Van Der Speeten K, Liberale G, Ceelen W.

2015-12-168 citations

10.1186/s12885-015-1954-x

Interventions

DRUGperioperative chemotherapy plus bevacizumab

preoperative and postoperative combination chemotherapy with bevacizumab

PROCEDUREcytoreductive surgery

complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.

DRUGIntraperitoneal Oxaliplatin

Pump-driven intraperitoneal administration of oxaliplatin

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
surgical morbidity and mortality	until 3 months after surgery and intraperitoneal chemotherapy	This will be estimated with the Dindo-Clavien classification

Secondary

Measure	Time frame	Description
progression free survival	24 months after finishing the adjuvant chemotherapy	time interval between date of surgery and disease progression or death
overall survival	24 months after finishing the adjuvant chemotherapy	calculated from date of surgery until death
treatment completion rate	day 1 after termination of adjuvant chemotherapy	percentage of patients receiving all planned courses
chemotherapy-related toxicity	1 month after termination of the adjuvant chemotherapy	percentage of patients experiencing chemotherapy-related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) scoring system
pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab	day 1 after termination of the cytoreductive surgery	will be scored with a 3 level regression scale

Countries

Belgium

Outcome results

None listed