|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
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: | 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
| Study ID Numbers: | CDR0000068675, NCI-01-C-0143 |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020631 History of Changes |
| Health Authority: | United States: Federal Government |
|
radiation fibrosis |
|
Anti-Inflammatory Agents Lung Diseases, Interstitial Fibrosis Wounds and Injuries Disorders of Environmental Origin Pirfenidone Respiratory Tract Diseases Analgesics, Non-Narcotic |
Lung Diseases Radiation Pneumonitis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Pneumonia Radiation Injuries |
|
Anti-Inflammatory Agents Lung Diseases, Interstitial Antineoplastic Agents Fibrosis Physiological Effects of Drugs Wounds and Injuries Disorders of Environmental Origin Pharmacologic Actions Pirfenidone Pathologic Processes Respiratory Tract Diseases |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lung Diseases Anti-Inflammatory Agents, Non-Steroidal Radiation Pneumonitis Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Radiation Injuries |
