Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Rectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. Giving more
      than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy
      together with combination chemotherapy before surgery may shrink the tumor so it can be
      removed. It is not yet known whether giving radiation therapy together with capecitabine is
      more effective with or without oxaliplatin before surgery in treating rectal cancer.

      PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and
      oxaliplatin to see how well they work compared to radiation therapy and capecitabine in
      treating patients who are undergoing surgery for stage II or stage III rectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and
           capecitabine with vs without oxaliplatin followed by total mesorectal excision, in terms
           of the rate of complete surgical resection, in patients with resectable stage II or III
           rectal cancer.

      Secondary

        -  Compare overall and disease-free survival of patients treated with these regimens.

        -  Compare clinical tumor response in patients treated with these regimens.

        -  Compare acute and late toxicity of these regimens in these patients.

        -  Determine biological parameters that predict tumor response and treatment-related
           toxicity in patients treated with these regimens.

        -  Compare sphincter preservation and function in patients treated with these regimens.

      OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients undergo radiotherapy once daily 5 days a week and receive capecitabine
           once daily 5 days a week in weeks 1-5.

        -  Arm II: Patient undergo radiotherapy and receive capecitabine as in arm I. Patients also
           receive oxaliplatin once weekly in weeks 1-5.

      All patients undergo total mesorectal excision 6 weeks after completion of chemoradiotherapy.

      PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
    

Intervention name(s): capecitabine; oxaliplatin; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the rectum; stage II rectal cancer; stage III rectal cancer