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. Combining more than one drug or combining radiation therapy with
      chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and
      mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus
      radiation therapy for anal cancer.

      PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus
      radiation therapy to see how well it works compared to fluorouracil and cisplatin plus
      radiation therapy in treating patients with stage II or stage III anal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the initial and total local and distant failure rates in patients with anal
           canal cancer treated with either fluorouracil (5-FU) plus mitomycin concurrently with
           radiotherapy or 5-FU plus cisplatin followed by 5-FU plus cisplatin concurrently with
           radiotherapy.

        -  Identify any differences in local control and colostomy rates at 2 years in patients
           treated with these regimens.

        -  Determine any difference in colostomy free, disease free, or overall survival in
           patients treated with these regimens.

        -  Compare the toxic effects of these regimens in these patients.

        -  Evaluate the prognostic effects of tumor markers P53 overexpression, human papilloma
           virus status, and enzyme HAP1 in patients treated with these regimens.

      OUTLINE: This is a randomized study. Patients are stratified according to gender, nodal
      status (positive vs negative), and primary tumor size (greater than 2 cm to 5 cm vs greater
      than 5 cm). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on
           days 1 and 29 and mitomycin IV on days 1 and 29 with concurrent radiotherapy.

        -  Arm II: Patients receive induction chemotherapy comprising 5-FU IV continuously over 96
           hours beginning on days 1, 29, 57, and 85 and cisplatin IV over 1 hour on days 1, 29,
           57, and 85. Beginning on day 57, patients receive concurrent radiotherapy.

      In both arms, radiotherapy is administered daily, 5 days a week, for 5-6.5 weeks. Patients
      with T3, T4, or N+ lesions or T2 lesions with residual disease receive additional
      radiotherapy to a reduced field.

      Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study within 5 years.
    

Intervention name(s): cisplatin; fluorouracil; mitomycin C; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Fluorouracil; Mitomycins; Mitomycin
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