Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

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Brief Title

Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

Official Title

A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal

Brief 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


        -  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

        -  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

      PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study within 5 years.

Study Phase

Phase 3

Study Type



Anal Cancer




* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 1998

Completion Date

December 2016

Primary Completion Date

October 2005

Eligibility Criteria


          -  Histologically confirmed primary squamous, basaloid, or cloacogenic carcinoma of the
             anal canal, other than carcinoma in situ

               -  T2-4, Any N, M0 (stage II or III)

          -  No local or regional recurrence after local excision or abdominal peritoneal resection



          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  Not specified


          -  WBC at least 4,000/mm^3

          -  Absolute neutrophil count at least 1,800/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 g/dL


          -  Bilirubin less than 1.4 mg/dL


          -  Creatinine no greater than 1.5 mg/dL OR

          -  Creatinine clearance at least 80 mL/min


          -  No uncompensated heart disease

          -  No uncontrolled high blood pressure


          -  No AIDS

          -  No active systemic infection

          -  No uncontrolled diabetes

          -  No other prior malignancy within the past 5 years except nonmelanoma skin cancer

          -  No mental condition that would preclude study participation

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception


        Biologic therapy:

          -  Prior epoetin alfa allowed in lieu of blood transfusions


          -  At least 5 years since prior chemotherapy

        Endocrine therapy:

          -  Not specified


          -  At least 5 years since prior radiotherapy


          -  No prior surgery of anal canal except for biopsy of study site




18 Years - 120 Years

Accepts Healthy Volunteers



Jaffer A. Ajani, MD, , 

Location Countries

South Africa

Location Countries

South Africa

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Radiation Therapy Oncology Group


 National Cancer Institute (NCI)

Study Sponsor

Jaffer A. Ajani, MD, Study Chair, M.D. Anderson Cancer Center

Verification Date

December 2016