A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
- 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
Allocation: Randomized, Primary Purpose: Treatment
Accrual rate in months 10 to 12 (phase II)
Austin Obichere, MD
University College London Hospitals