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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00020631

Enrollment

Unknown

Registered

2003-01-27

Start date

2001-10-31

Completion date

2007-10-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Fibrosis

Keywords

radiation fibrosis

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.

Interventions

DRUGpirfenidone

Study design

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities) * At least moderate impairment in at least 1 of the following principal functional abilities: * Range of motion * Strength * Edema * Swallowing * Prior radiation for cancer received more than 6 months ago * No evidence of recurrent or metastatic cancer * No history of collagen vascular disease * No positive antinuclear antibody PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Hepatitis B and C negative Renal: * Not specified Other: * HIV negative * No evidence of second primary cancer * No life-threatening situation requiring rehabilitation intervention * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent anticancer immunotherapy Chemotherapy: * No concurrent anticancer chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * No concurrent anticancer radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer investigational agents * Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026