A randomized multicenter clinical trial for patients with multi-organ, colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone

Radboud University Medical Centre Nijmegen (Netherlands)0 sites478 target enrollmentFebruary 7, 2020

Overview

No summary available.

Registry

who.int

Start Date

February 7, 2020

End Date

July 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Radboud University Medical Centre Nijmegen (Netherlands)

•1\. Patients with CRC metastases in \= 2 different organs and
•1\.1\. \>3 extrahepatic metastases or
•1\.2\. \>5 hepatic metastases not located to one lobe or
•1\.3\. \=1 hepatic metastases and either positive para\-aortal lymph nodes or celiac lymph nodes or adrenal metastases or pleural carcinomatosis or peritoneal carcinomatosis
•1\.4\. The primary tumor is excluded as metastatic site
•2\. Feasible radical tumor debulking. Incomplete tumor debulking is allowed only if at least 80% of metastases can be treated
•3\. Age \>\= 18 years
•4\. WHO performance status 0 – 1
•5\. Life expectancy of at least 12 weeks
•6\. Written informed consent

•1\. Prior (neo\-)adjuvant chemotherapy for \< 6 months after last treatment and first detection of extrahepatic metastases, except for neoadjuvant capecitabin in the context of chemoradiation for rectal carcinoma
•2\. Candidates for HIPEC
•3\. Patients with liver metastases only
•4\. Evidence of brain metastases
•5\. History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in\-situ carcinoma of any organ. Patients with other malignancies are eligible if they have remained disease free for at least 5 years
•6\. History of cardiac disease:
•6\.1\. Congestive heart failure \>NYHA class 2
•6\.2\. Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening)
•6\.3\. Cardiac arrhythmias requiring anti\-arrhythmic therapy (beta blockers or digoxin are permitted)
•7\. Uncontrolled hypertension. Blood pressure must be \=160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 3 separate measurements on at least 2 separate days