Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
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|ClinicalTrials.gov Identifier: NCT00423293|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : May 29, 2013
Last Update Posted : February 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer||Drug: fluorouracil Drug: mitomycin C Radiation: Intensity-modulated radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2006|
|Primary Completion Date :||February 2009|
|Study Completion Date :||December 2016|
5-FU + Mitomycin + IMRT
5-FU + Mitomycin + IMRT
1000 mg/m^2/day 96-hour continous infusion (M-F) starting on day 1 and again on day 29 of radiation therapy.Drug: mitomycin C
10 mg/m^2 intravenous therapy on day 1 and day 29 of radiation therapy.Radiation: Intensity-modulated radiation therapy
Prescription dose depends on tumor staging.
T2N0: The primary tumor PTV (planning target volume) (PTVA) receives 50.4 Gy in 28 fractions (fx) at 1.8 Gy/fx. The nodal PTVs receive 42 Gy in 28 fx at 1.5 Gy/fx. PTVA receive 50.4 Gy in 28 fractions at 1.8 Gy/fx. PTV42 receive 42 Gy in 28 fx at 1.5 Gy/fx and will include all nodal regions.
T3N0 or T4N0: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. The nodal PTVs will receive 45 Gy in 30 fx at 1.5 Gy/fx. PTVA will receive 54 Gy in 30 fx at 1.80 Gy/fx. PTV45 will receive 45 Gy in 30 fx electively at 1.5 Gy/fx and will include all nodal regions.
For N+ disease: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. For involved nodes ≤ 3 cm in maximum dimension, the involved nodal PTV will receive 50.4 Gy in 30 fx at 1.68 Gy/fx. For involved nodes > 3 cm in maximum dimension, the involved nodal PTV will receive 54 Gy in 30 fx at 1.80 Gy/fx.
- Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events) [ Time Frame: From the start of treatment to 90 days ]
- Reproducibility of the Intensity-modulated Radiation Therapy Technique [ Time Frame: IMRT planning and dosing data is centrally reviewed for quality assurance ]
- Adverse Event Rates as Defined by CTCAE v 3.0 Within 90 Days From the Start of Study Treatment [ Time Frame: From the start of treatment to 90 days ]
- Clinical Complete Response Rate [ Time Frame: From registration to 8 and 12 weeks after treatment completion ]
- Radiotherapy Treatment Time [ Time Frame: From start to end of radiation therapy ]
- Efficacy of Treatment, in Terms of Locoregional Failure, Disease-free Survival, Time to Colostomy, Colostomy-free Survival, and Overall Survival [ Time Frame: From registration to date of failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423293
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|Study Chair:||Lisa A. Kachnic, MD||Boston Medical Center|