Clinical Trial: Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 C

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 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.


Detailed Summary:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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
Sponsor: Radiation Therapy Oncology Group

Current Primary Outcome: 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 ]

Original Primary Outcome: Gastrointestinal and genitourinary adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome:

  • Complete response at 8-12 weeks
  • Efficacy in terms of locoregional failure, disease-free survival, colostomy failure, colostomy-free survival, and overall survival
  • Reproducibility of the dose-painted intensity-modulated radiation therapy technique
  • Radiotherapy Treatment Time
  • Adverse event rates as defined by CTCAE v 3.0 during the first 90 days and after 90 days from the start of study treatment


Information By: Radiation Therapy Oncology Group

Dates:
Date Received: January 16, 2007
Date Started: December 2006
Date Completion:
Last Updated: December 30, 2016
Last Verified: December 2016