Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020631
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
Status:
COMPLETED
Status Verified Date:
2004-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-01-C-0143 | None | None | None |