- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00054301
Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast
- Primary tumor classified as T1, T2, or T3
- Candidate for breast-conserving surgery
- Must have undergone lumpectomy with negative margins or minimal margin involvement
- Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
- No evidence of metastatic disease
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- Adult
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC greater than 3,500/mm^3
- Granulocyte count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
No other malignancies within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- Prior contralateral breast cancer allowed if curatively treated more than 5 years previously
- No severe psychiatric or medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the involved breast
Surgery
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Patients are followed at 1 month and then every 3 months for 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shelli Hanks, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICC4102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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