Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT01086618|
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: systemic chemotherapy Procedure: adjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery||Phase 2 Phase 3|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Official Title:||A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||July 2013|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086618
|University College Hospital|
|London, England, United Kingdom, NW1 2BU|
|Principal Investigator:||Austin Obichere, MD||University College London Hospitals|