Status:
COMPLETED
Radiation Therapy in Treating Patients With Recurrent Breast Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant rad...
Detailed Description
OBJECTIVES: * To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to dete...
Eligibility Criteria
Inclusion
- Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
- Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
- Unifocal breast cancer recurrence
- Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
- Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
- Signed study-specific informed consent prior to study entry.
Exclusion
- Patients with distant metastatic disease
- Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
- Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
- Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
- Patients with Paget's disease of the nipple.
- Patients with skin involvement.
- Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
- Other malignancy, except non-melanomatous skin cancer, \< 5 years prior to participation in this study.
- Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
- Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.
Key Trial Info
Start Date :
September 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00945061
Start Date
September 23 2008
End Date
July 6 2018
Last Update
August 18 2020
Active Locations (3)
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1
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
3
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145