Status:
COMPLETED
Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Anal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil, and mitomycin C decreases the combined rate of gastrointestinal and genitourinary adverse...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the anal canal, including any of the following subtypes:
- Squamous cell
- Basaloid
- Cloacogenic
- Primary invasive disease
- T2-4, N0-3 disease
- Clinically positive small inguinal nodes (i.e., \< 1 cm in size) must be confirmed by biopsy (preferably fine-needle aspiration) within the past 6 weeks
- Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on exam or CT scan that are found to be ≥ 1.0 cm and are considered to be clinically positive
- 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
- HIV-positive patients without AIDS are eligible
- HIV test required for patients with clinical suspicion of 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
- Patients may be eligible if appropriate changes in management have resulted in adequate control of the above mentioned conditions
- 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:
- See Disease Characteristics
- No prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields
- No prior systemic chemotherapy for cancer of the anus
- No prior surgery for cancer of the anus that removed all macroscopic anal cancer
- No concurrent sargramostim (GM-CSF)
- No concurrent amifostine
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00423293
Start Date
December 1 2006
End Date
December 1 2016
Last Update
February 27 2019
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