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

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Trial Conditions
  • Anal Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- 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

Hepatic:

- Bilirubin less than 1.4 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 80 mL/min

Cardiovascular:

- No uncompensated heart disease

- No uncontrolled high blood pressure

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior epoetin alfa allowed in lieu of blood transfusions

Chemotherapy:

- At least 5 years since prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 5 years since prior radiotherapy

Surgery:

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

Gender: Both
Steward Physician(s)
  • Jaffer A. Ajani, MD
  • Al B. Benson, MD, FACP
  • Joel E. Tepper, MD
  • John S. MacDonald, MD
  • Michael G. Haddock, MD
Facilities
  • Saint Anne's Hospital - Completed
Trial Interventions
Drug
  • cisplatin
  • fluorouracil
  • mitomycin C
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Jaffer A. Ajani, MD
  • Al B. Benson, MD, FACP
  • Joel E. Tepper, MD
  • John S. MacDonald, MD
  • Michael G. Haddock, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00003596
Volunteers:  Not Accepting Healthy Volunteers

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