Spots Global Cancer Trial Database for Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
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Trial Identification
Brief Title: Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
Official Title: A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
Study ID: NCT00020631
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Contact Details
Name: Kevin Camphausen, MD
Affiliation: NCI - Radiation Oncology Branch; ROB
Role: PRINCIPAL_INVESTIGATOR
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