NCT00020631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2001

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 19, 2013

Status Verified

April 1, 2004

First QC Date

July 11, 2001

Last Update Submit

June 17, 2013

Conditions

Radiation Fibrosis

Keywords

radiation fibrosis

Interventions

pirfenidoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Radiation Fibrosis Syndrome

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsRadiation InjuriesWounds and Injuries

Study Officials

  • Kevin Camphausen, MD

    NCI - Radiation Oncology Branch; ROB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

October 1, 2001

Study Completion

October 1, 2007

Last Updated

June 19, 2013

Record last verified: 2004-04

Locations

US(1)