Colorectal Cancer Clinical Trial
Official title:
A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
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.
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
;
Allocation: Randomized, Primary Purpose: Treatment
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