EUCTR2011-005003-32-NL
Active, not recruiting
Phase 1
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.
VU University Medical Center, Department of Medical Oncology0 sites478 target enrollmentMarch 5, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- multi-organ metastatic colorectal cancer
- Sponsor
- VU University Medical Center, Department of Medical Oncology
- Enrollment
- 478
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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