Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054301
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2003-02-05
Brief Title:
Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates
Status:
COMPLETED
Status Verified Date:
2020-07
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 Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer
Detailed Description:
OBJECTIVES
Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy before whole breast irradiation in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast
Determine the local recurrence rates in patients treated with this regimen
Determine the cosmetic outcome in patients treated with this regimen
OUTLINE Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity Postoperatively patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks
Patients are followed at 1 month and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2 years
Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy before whole breast irradiation in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast
Determine the local recurrence rates in patients treated with this regimen
Determine the cosmetic outcome in patients treated with this regimen
OUTLINE Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity Postoperatively patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks
Patients are followed at 1 month and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 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