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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020631 |
Purpose
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 | Intervention |
|---|---|
|
Radiation Fibrosis |
Drug: pirfenidone |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis |
| Study Start Date: | October 2001 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00020631 History of Changes |
| Obsolete Identifiers: | NCT00014924 |
| Other Study ID Numbers: | CDR0000068675, NCI-01-C-0143 |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
|
radiation fibrosis |
|
Fibrosis Radiation Pneumonitis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Lung Injury Radiation Injuries Wounds and Injuries Pirfenidone Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents |
