- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin Camphausen, MD, NCI - Radiation Oncology Branch; ROB
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Wounds and Injuries
- Lung Diseases, Interstitial
- Lung Injury
- Radiation Injuries
- Fibrosis
- Radiation Pneumonitis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- CDR0000068675
- NCI-01-C-0143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Radiation Fibrosis
-
Massachusetts General HospitalRecruitingMyocardial Fibrosis | Breast Cancer | Radiation-Induced FibrosisUnited States
-
Mayo ClinicEnrolling by invitationBreast Reconstruction | Radiation Dermatitis | Radiation Fibrosis | Fat GraftingUnited States
-
University of ChicagoEnrolling by invitationBreast Cancer | Radiation Fibrosis | Fat GraftingUnited States
-
Sanford HealthCompletedRadiation Induced Fibrosis to the Head and NeckUnited States
-
Shaw Cancer CenterSteadman Philippon Research InstituteRecruitingRadiation Induced FibrosisUnited States
-
Meshalkin Research Institute of Pathology of CirculationRecruitingBreast Neoplasms | Radiation Pneumonitis | Radiation Induced Fibrosis | Radiation PneumoniaRussian Federation
-
National Cancer Institute (NCI)CompletedFibrosis | Radiation InjuriesUnited States
-
Weill Medical College of Cornell UniversityActive, not recruitingMalignant Neoplasm of Breast Stage IUnited States
-
Chang Gung Memorial HospitalRecruitingRadiation-Induced Fibrosis in Patients With Head and Neck CancerTaiwan
Clinical Trials on pirfenidone
-
Jorge L PooCompletedCirrhosis, Liver | Liver Fibrosis | Chronic Liver Disease
-
Capital Medical UniversityActive, not recruiting
-
Fujian Medical University Union HospitalBeijing Continent Pharmaceutical Co, Ltd.RecruitingAcute Lung Injury | PreventionChina
-
Huilan ZhangUnknownPneumonia | Novel Coronavirus Pneumonia | PirfenidoneChina
-
Beijing Continent Pharmaceutical Co, Ltd.Recruiting
-
Genentech, Inc.Hoffmann-La RocheCompletedIdiopathic Pulmonary FibrosisUnited States
-
Hospices Civils de LyonRecruitingProgressive Idiopathic Pulmonary FibrosisFrance
-
Stanford UniversityGenentech, Inc.CompletedBronchiolitis Obliterans | Graft Vs Host DiseaseUnited States
-
Instituto de investigación e innovación biomédica...RecruitingSilicosis | Progressive Massive Fibrosis | Complicated SilicosisSpain
-
Zagazig UniversityCompletedHypersensitivity PneumonitisEgypt