Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.
PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis|
|Study Start Date:||October 2001|
|Study Completion Date:||October 2007|
- Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.
OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Kevin Camphausen, MD||NCI - Radiation Oncology Branch; ROB|