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Clinical Trials/NCT00054301
NCT00054301
Completed
Phase 2

Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates

Case Comprehensive Cancer Center1 site in 1 country2 target enrollmentNovember 2002
ConditionsBreast Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Case Comprehensive Cancer Center
Enrollment
2
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
5 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
November 2002
End Date
October 2004
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Time Frame: Patients are followed at 1 month and then every 3 months for 2 years

Study Sites (1)

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