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.

Recruiting

• Conditions: multi-orgaan gemetastaseerd colorectaal carcinoom; multi-organ metastatic colorectal cancer; 10017991

• Registration Number: NL-OMON54652
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 408

Inclusion Criteria

Patients with indication for first line palliative systemic treatment for
metatastatic colorectal cancer, with CRC metastases in >= 2 different organs,
minimum age 18 years, life expectancy of at least 12 weeks

Exclusion Criteria

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, candidates for HIPEC, patients
with livermetastases only, evidence of brain metastases, history of cardiac
disease, uncontrolled hypertension, uncontrolled infections, pregnancy or
breast feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is overall survival counting from the date of study<br /><br>inclusion to the date of death. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives include: 1) Progression free survival (PFS), 2) To<br /><br>determine the safety and efficacy of the additional local treatment, 3) To<br /><br>determine quality of life in the two study arms, 4) To study whether CEA can<br /><br>predict for treatment response and survival, 5) To determine the relation of<br /><br>genomic (instability) profiles and response to therapy, 6) To study the<br /><br>relation of miRNA profiles and response to therapy, 7) To study<br /><br>(phospho)proteomic profiles in relation to response to therapy, 8) To study<br /><br>circulating endothelial cells (CECs) and cellular immunity in relation to<br /><br>response to therapy.</p><br>