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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00020631
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase N/A
Start date October 2001
Completion date October 2007

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