Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030680
Status:
COMPLETED
Last Update Posted:
2013-08-27
First Post:
2002-02-14
Brief Title:
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Status:
COMPLETED
Status Verified Date:
2013-08
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 Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses
PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses
Detailed Description:
OBJECTIVES
Determine the efficacy of moderate-dose radiotherapy in terms of local control in patients with aggressive fibromatoses
Determine the acute and late side-effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive radiotherapy 5 days a week for 55 weeks for a total of 56 Gy in 28 fractions
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 3 years
Determine the efficacy of moderate-dose radiotherapy in terms of local control in patients with aggressive fibromatoses
Determine the acute and late side-effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive radiotherapy 5 days a week for 55 weeks for a total of 56 Gy in 28 fractions
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-22998 | None | None | None |
| EORTC-62991 | None | None | None |