NCT01086618

Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	systemic chemotherapy
PROCEDURE	adjuvant therapy
PROCEDURE	quality-of-life assessment
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2010-03-15
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom