Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given alone or together with surgery in treating patients with colorectal cancer.
PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and compares it with surgery followed by chemotherapy in treating patients with metastatic colorectal cancer that can not be removed by surgery.
|Colorectal Cancer||Drug: systemic chemotherapy Procedure: adjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease|
- Accrual rate in months 10 to 12 (phase II)
- Overall survival for ≥ 2 years (phase III)
- Morbidity of surgery (phase II)
- Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
- Morbidity of chemotherapy and surgery (phase III)
- Quality of life (phase III)
- Economic evaluation (phase III)
|Study Start Date:||January 2010|
|Study Completion Date:||July 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- To determine whether overall survival is improved in patients with asymptomatic, unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control arm): Patients receive systemic chemotherapy according to standard local practice. Patients who develop symptoms from their primary tumor receive treatment as required including surgery, if indicated.
- Arm II (experimental arm): Patients undergo surgery at the discretion of the surgeon. Beginning 8 weeks after completion of surgery, patients receive chemotherapy according to standard local practice.
Patients complete quality-of-life questionnaires (EQ-5D) at baseline and then periodically during and after completion of study treatment.
After completion of study treatment, patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086618
|University College Hospital|
|London, England, United Kingdom, NW1 2BU|
|Principal Investigator:||Austin Obichere, MD||University College London Hospitals|