A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal
A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the anal canal, including any of the following subtypes:
Primary invasive disease
T2-4, N0-3 disease
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
ALT and AST < 3 times upper limit of normal
Absolute neutrophil count ≥ 1,800/mm³
Serum creatinine ≤ 1.5 mg/dL
Platelet count ≥ 100,000/mm³
Bilirubin < 1.4 mg/dL
WBC ≥ 3,000/mm³
INR ≤ 1.5
No known AIDS
No other invasive malignancy within the past 3 years except for nonmelanomatous skin cancer
No severe, active comorbidity, defined as any of the following:
Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
Transmural myocardial infarction within the past 6 months
Acute bacterial or fungal infection requiring IV antibiotics
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled high blood pressure, that in the opinion of the patient's treating physician, requires an immediate change in management
Other immunocompromised status (e.g., organ transplantation or chronic glucocorticoid use)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Los Angeles, California 90089-9181, United States
Sacramento, California 95815, United States
Aurora, Colorado 80045, United States
Boca Raton, Florida 33486, United States
Fort Lauderdale, Florida 33308, United States
Jacksonville, Florida 32207, United States
Chicago, Illinois 60611-3013, United States
Maywood, Illinois 60153, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Baltimore, Maryland 21201, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
City of Saint Peters, Missouri 63376, United States
St Louis, Missouri 63110, United States
Keene, New Hampshire 03431, United States
Lebanon, New Hampshire 03756-0002, United States
Camden, New Jersey 08103, United States
Marlton, New Jersey 08053, United States
Vineland, New Jersey 08360, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Rochester, New York 14642, United States
Charlotte, North Carolina 28233-3549, United States
Salem, Ohio 44460, United States
Drexel Hill, Pennsylvania 19026, United States
Philadelphia, Pennsylvania 19107-5541, United States
Reading, Pennsylvania 19612-6052, United States
Kingsport, Tennessee 37662, United States
Fort Worth, Texas 76104, United States
Murray, Utah 84157, United States
Green Bay, Wisconsin 54301-3526, United States