Clinical Trial: Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Brief Summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.
Detailed Summary:
OBJECTIVES:
- Determine the efficacy of moderate-dose radiotherapy, in terms of local control, in patients with aggressive fibromatoses.
- Determine the acute and late side-effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive radiotherapy 5 days a week for 5.5 weeks for a total of 56 Gy in 28 fractions.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Current Primary Outcome: Local control as assessed by MRI at 3 years
Original Primary Outcome:
Current Secondary Outcome:
- Toxicity as assessed by CTC 2.0
- Response as assessed by MRI
Original Secondary Outcome:
Information By: European Organisation for Research and Treatment of Cancer - EORTC
Dates:
Date Received: February 14, 2002
Date Started: November 2001
Date Completion:
Last Updated: August 26, 2013
Last Verified: August 2013
