NCT00020631

Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Fibrosis

Interventions

Type	Name	Description
DRUG	pirfenidone

Timeline

• Start date: 2001-10-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States