A study comparing the effect of chemotherapy with the effect of chemotherapy plus local removal of metastases for patients with cancer of the large bowel which has spread to multiple organs.
- Conditions
- multi-organ metastatic colorectal cancerMedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005003-32-NL
- Lead Sponsor
- VU University Medical Center, Department of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 478
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 239
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 239
Prior (neo-)adjuvant chemotherapy < 6 months after last treatment and first detection of metastasis (except for neoadjuvant capecitabin in the context of chemoradiation for rectal carcinoma), candidates for HIPEC, evidence of brain metastases, history of cardiac disease, uncontrolled hypertension, uncontrolled infections, pregnancy or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method