Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: 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 fluorouracil and leucovorin, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill
      any tumor cells that remain after surgery. It is not yet known whether radiation therapy is
      more effective with or without chemotherapy when given before surgery for rectal cancer.

      PURPOSE: This randomized phase III trial is studying radiation therapy given together with
      fluorouracil and leucovorin to see how well they work compared to giving radiation therapy
      alone before surgery in treating patients with stage II or stage III rectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the recurrence-free and overall survival of patients with resectable stage II or
           III adenocarcinoma of the rectum treated with neoadjuvant radiotherapy with or without
           concurrent chemotherapy comprising fluorouracil and leucovorin calcium followed by
           surgery and adjuvant fluorouracil and leucovorin calcium.

      OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
      according to participating center, gender, location of the tumor relative to the anal margin
      (0-5 cm vs > 5 cm), and tumor stage (T3 vs T4). Patients are randomized to 1 of 2 treatment
      arms.

        -  Neoadjuvant therapy: Patients are randomized to 1 of 2 neoadjuvant therapy arms.

             -  Arm I: Patients receive leucovorin calcium IV and fluorouracil IV over 15 minutes
                on days 1-5. Treatment repeats every 28 days for 2 courses in the absence of
                disease progression or unacceptable toxicity. Patients also undergo concurrent
                radiotherapy 5 days a week for 5 weeks.

             -  Arm II: Patients undergo radiotherapy as in arm I.

        -  Surgery: In both arms, patients undergo surgical resection within 3-10 weeks after
           completing neoadjuvant therapy.

        -  Adjuvant therapy: Within 3-10 weeks after surgery, all patients receive adjuvant
           chemotherapy comprising leucovorin calcium IV and fluorouracil IV over 15 minutes on
           days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease
           progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 6 months for at least 5
      years.

      PROJECTED ACCRUAL: A total of 762 patients will be accrued for this study.
    

Intervention name(s): fluorouracil; leucovorin calcium; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Leucovorin; Fluorouracil; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum