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| Descriptive Information Fields | |||||
| Brief Title † | Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer | ||||
| Official Title † | A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Cancer-Related Problem/Condition | ||||
| Intervention † | Drug: pirfenidone | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | October 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00020631 | ||||
| Organization ID | CDR0000068675 | ||||
| Secondary IDs †† | NCI-01-C-0143 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2004 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||