Status and phase
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Study type
Funder types
Identifiers
About
RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.
Full description
OBJECTIVES:
Phase II
Primary
Secondary
Phase III
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, T stage (T2 vs T3 vs T4), and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at weeks 12 and 26, and then every 6 months for 2 years.
Patients are followed every 2 weeks for 8 weeks, at week 26, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 678 patients (80 [40 per treatment arm] for phase II and 598 [299 per treatment arm] for phase III) will be accrued for this study within 2-5 years.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell anal carcinoma
Keratinizing or non-keratinizing
The following stages are eligible:
Tumor located in the anal canal OR in the anal margin and infiltrating the anal canal
No primary adenocarcinoma of the anus
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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