Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
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|ClinicalTrials.gov Identifier: NCT00020631|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment|
|Radiation Fibrosis||Drug: pirfenidone|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
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): NCT00020631
|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|