Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. It is not yet known which combination chemotherapy regimen is
      more effective in treating patients who have undergone surgery for high-risk colorectal
      cancer.

      PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in
      treating patients with high-risk stage II or stage III colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy
           lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III
           colorectal cancer.

        -  To conduct an economic analysis of the cost effectiveness of these regimens.

        -  To compare the randomization methodologies used in this study.

      OUTLINE: This is a multicenter study. Patients are stratified according to participating
      center's recruitment potential. Patients are randomized (within 10 weeks after surgery and
      before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment
      regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is
      determined by the participating center.

        -  Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described
           below)combination chemotherapy (6 additional courses if patient already received 6
           courses) for treatment lasting a total of 24 weeks.

        -  Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no
           additional courses if patient already received 6 courses) for treatment lasting a total
           of 12 weeks.

      The two adjuvant combination chemotherapy regimens are administered as follows:

        -  OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously
           over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of
           disease progression or unacceptable toxicity.

        -  XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice
           daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of
           disease progression or unacceptable toxicity.

      Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC
      QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.

      After completion of study treatment, patients are followed periodically for up to 7 years.

      Peer Reviewed and Funded by Medical Research Council (MRC)
    

Intervention name(s): capecitabine; fluorouracil; oxaliplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given orally; Given IV; Given IV
Intervention MeSH terms: Capecitabine; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II colon cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer