Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 88
- Locations
- 47
- Primary Endpoint
- Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Phase II
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Primary
-
Compare the early clinical response (tumor response at 8 weeks) of patients with locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin vs mitomycin and fluorouracil.
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Secondary
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Compare the feasibility of these regimens in these patients.
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Compare the acute toxicity of these regimens in these patients.
-
Compare patient compliance to these regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell anal carcinoma
- •Keratinizing or non-keratinizing
- •The following stages are eligible:
- •T2, N0, M0 with maximum tumor diameter at least 4 cm
- •T3-T4, N0, M0
- •Any T, N1-N3, M0
- •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:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Not specified
- •Creatinine less than 1.4 mg/dL
- •Cardiovascular
- •No grade I angina pectoris with clinical symptoms within the past 3 months
- •No grade II-IV angina pectoris within the past 3 months
- •No stage II or greater distal arteritis
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No other concurrent radiotherapy
- •No prior colostomy
- •No prior treatment for anal cancer
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
Event-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
Secondary Outcomes
- Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
- Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)
- Colostomy-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
- Overall survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
- Local control as measured by Gray at 12 and 26 weeks, then every 6 months thereafter
- Late toxicity as measured by RTOG and EROTC every 6 months after week 26
- Quality of life as measured by EORTC Quality of Life Questionnaire-C30 and ASCT at 12 and 26 weeks, then every 6 months for 2 years after entry