Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
Recruitment status was Active, not recruiting
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 fluorouracil 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.
Drug: mitomycin C
Radiation: intensity-modulated radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Dose-Painted IMRT in Combination With 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal|
- Gastrointestinal and genitourinary adverse events ≥ grade 2 as defined by CTCAE v 3.0 [ Designated as safety issue: Yes ]
- Reproducibility of the intensity-modulated radiation therapy technique [ Designated as safety issue: No ]
- Adverse event rates as defined by CTCAE v 3.0 within 90 days from the start of study treatment [ Designated as safety issue: Yes ]
- Clinical complete response rate at 8 weeks after completion of treatment [ Designated as safety issue: No ]
- Radiotherapy treatment time [ Designated as safety issue: No ]
- Efficacy of treatment, in terms of locoregional failure, disease-free survival, time to colostomy, colostomy-free survival, and overall survival [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil, and mitomycin C decreases the combined rate of gastrointestinal and genitourinary adverse events (grade II or greater) by at least 15% in the first 90 days after the start of treatment in patients with primary invasive carcinoma of the anal canal compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on clinical trial RTOG 98-11.
- Determine the feasibility of performing IMRT in these patients in a cooperative group setting.
- Evaluate adverse events experienced by patients treated with this regimen and to decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by 15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11.
- Evaluate the total duration of radiotherapy.
- Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free survival, time to colostomy, colostomy-free survival, and overall survival of these patients.
- Determine clinical complete response at 8 weeks after completion of study treatment.
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.