Anal Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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