Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002873
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III TRIAL TO EVALUATE BRACHYTHERAPY AS THE SOLE METHOD OF RADIATION THERAPY FOR STAGE I AND II BREAST CARCINOMA
Status:
COMPLETED
Status Verified Date:
2008-02
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 may kill any tumor cells remaining after surgery
PURPOSE Phase III trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer
PURPOSE Phase III trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES I Evaluate the technical feasibility and reproducibility cosmetic results complication rates and local cancer control rate experience with brachytherapy used as the sole method of radiotherapy in women with stage III breast cancer treated with tylectomy who have histologically assessed negative surgical margins less than 4 positive axillary nodes and no extracapsular nodal extension or extensive intraductal component II Reduce the total treatment time of breast irradiation from 6 weeks to 4-5 days in these patients
OUTLINE Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery All patients receive brachytherapy to the target volume as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin using iridium-192 implants for dose distribution to five planes Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institutions discretion Patients are followed at 2 and 6 weeks after treatment then at 3 6 9 and 12 months then every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 46 patients will be accrued in each group high-dose rate vs low-dose rate over 2 years
OUTLINE Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery All patients receive brachytherapy to the target volume as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin using iridium-192 implants for dose distribution to five planes Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institutions discretion Patients are followed at 2 and 6 weeks after treatment then at 3 6 9 and 12 months then every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 46 patients will be accrued in each group high-dose rate vs low-dose rate over 2 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 |
|---|---|---|---|
| CDR0000065157 | None | None | None |