Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Condition: Anal Cancer
MeSH terms: Anus Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining chemotherapy with radiation therapy may kill more tumor cells.

      PURPOSE: This randomized phase III trial is studying different regimens of giving combination
      chemotherapy together with radiation therapy and comparing how well they work in treating
      patients with stage II or stage III anal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of concurrent chemotherapy and radiotherapy with or without
           neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or
           III anal canal cancer.

        -  Compare the efficacy of two levels of radiation dose in patients with stage II or III
           anal canal cancer.

        -  Compare the sphincter conservation of the anus by these regimens.

        -  Compare the effect of these regimens on survival and quality of life of these patients.

      OUTLINE: This is a randomized, multicenter study.

      Patients are randomized to one of four treatment arms.

        -  Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV over 24
           hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2
           courses. Beginning 4 weeks later, patients receive chemoradiotherapy. This regimen
           consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on
           day 1 or 2 and repeated 4 weeks later, plus pelvic radiotherapy beginning on day 1 and
           continuing for 5 weeks (once a day, 5 days/week). Patients receive low dose radiotherapy
           directly to the tumor beginning 3 weeks later and continuing for 2 weeks.

        -  Arm II: Patients receive induction chemotherapy and chemoradiotherapy as in arm I, plus
           high dose radiotherapy directly to the tumor.

        -  Arm III (control arm): Patients receive chemoradiotherapy and low dose radiotherapy to
           the tumor as in arm I.

        -  Arm IV: Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in
           arm II.

      After study treatment is completed, patients with nonfixed inguinal tumors may undergo
      surgical resection followed by radiotherapy or radiotherapy alone. Patients with fixed
      inguinal tumors may receive further radiotherapy alone.

      Quality of life is assessed before treatment, at 2 months after completion of treatment, and
      at 5 years.

      Patients are followed every 4 months for 2 years, every 6 months for 3 years, then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
    

Intervention name(s): cisplatin; fluorouracil; neoadjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II anal cancer; stage III anal cancer; squamous cell carcinoma of the anus; cloacogenic carcinoma of the anus; basaloid carcinoma of the anus