Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104702
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2005-03-03
Brief Title:
Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70 Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy
Status:
COMPLETED
Status Verified Date:
2013-09
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:
GERICO03
Brief Summary:
RATIONALE Radiation therapy uses high-energy x rays to kill tumor cells Giving radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer
PURPOSE This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine reproducibility of localized and concentrated adjuvant radiotherapy in terms of isodose curve and dose heterogeneity in older women with stage I or II breast cancer
Secondary
Determine the impact of this regimen on Katzs Activity of Daily Living score and Lawtons Instrumental Activity of Daily Living score in these patients
Determine relapse-free survival of patients treated with this regimen
Determine overall and specific survival of patients treated with this regimen
Determine the cosmetic result as assessed by the patient surgeon and radiologist of this regimen in these patients
Determine the direct and indirect costs of this regimen in these patients
OUTLINE This is a multicenter open-label nonrandomized study
Patients undergo surgery After surgery patients undergo radiotherapy twice daily for 5 days
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Determine reproducibility of localized and concentrated adjuvant radiotherapy in terms of isodose curve and dose heterogeneity in older women with stage I or II breast cancer
Secondary
Determine the impact of this regimen on Katzs Activity of Daily Living score and Lawtons Instrumental Activity of Daily Living score in these patients
Determine relapse-free survival of patients treated with this regimen
Determine overall and specific survival of patients treated with this regimen
Determine the cosmetic result as assessed by the patient surgeon and radiologist of this regimen in these patients
Determine the direct and indirect costs of this regimen in these patients
OUTLINE This is a multicenter open-label nonrandomized study
Patients undergo surgery After surgery patients undergo radiotherapy twice daily for 5 days
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20501 | None | None | None |
| FRE-FNCLCC-GERICO-030303 | None | None | None |