Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases
- Sponsor
- Radboud University Medical Center
- Study ID
- NCT01792934
- Status
- Active Not Recruiting
Conditions
- Multi-organ Metastatic Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- XELOX regimen according to standard procedures — DRUG
- FOLFOX regimen according to standard procedures — DRUG
- Surgery — PROCEDURE
- radiofrequency ablation (RFA) — OTHER
- transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI-)TACE) — OTHER
- stereotactic body radiation therapy (SBRT) — RADIATION
- Bevacizumab — DRUGmay be added to both regimens according to standard procedures
- tumor biopsy — PROCEDUREat baseline (diagnostic or study) biopsy and after 3 or 4 cycles an optional tumor biopsy
Study Details
The purpose of this study is to compare overall survival rates of colorectal cancer patients with multi-organ metastases with an indication for first line systemic treatment randomized for treatment with combination chemotherapy or treatment with combination chemotherapy and additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and SBRT, depending on best clinical judgement according to a standardized treatment algorithm. Our hypothesis is that maximal tumor debulking in addition to systemic treatment with chemotherapy and biologicals will provide an improvement in progression free and overall survival in this patient group.
Key Dates
- First listed
- Feb 15, 2013
- Start date
- May 31, 2013
- Status verified
- Mar 2025
- Primary completion
- Jan 31, 2025
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 478 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: XELOX or FOLFOX regimenXELOX or FOLFOX regimen
- Experimental: XELOX or FOLFOX regimen and maximal tumor debulkingXELOX or FOLFOX regimen and maximal tumor debulking including Surgery, radiofrequency ablation (RFA), transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI)-TACE) or stereotactic body radiation therapy (SBRT).
Primary Outcome Measure
Overall survival [ Time Frame: from date of study inclusion until the date of death or until the end of follow up, assessed up to 10 years ]