Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
NCT ID: NCT00185744
Last Updated: 2025-03-20
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
121 participants
INTERVENTIONAL
2002-09-30
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Accelerated Partial Breast Irradiation
lumpectomy with accelerated partial breast irradiation
Intra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy
Lumpectomy
Intracavitary Brachytherapy
5 day treatment
Accelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
Stereotactic APBI
4 day treatment
Standard Therapy
lumpectomy and whole breast irradiation
Lumpectomy
Whole Breast Radiotherapy
six and a half week treatment
Interventions
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Intra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy
Lumpectomy
Whole Breast Radiotherapy
six and a half week treatment
Intracavitary Brachytherapy
5 day treatment
Accelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
Stereotactic APBI
4 day treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
3. Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Exclusion Criteria
2. Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years
3. Pregnant women
4. Immunocompromised
5. Poorly controlled insulin dependent diabetes
6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
7. Breast cancer that involves skin or chest wall
8. Multifocal or Multicentric breast cancer
9. Invasive lobular carcinoma
10. Diffuse microcalcifications on mammography
11. Invasive carcinoma with extensive intraductal component (EIC)
12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
40 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Frederick M. Dirbas
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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Horst KC, Fasola C, Ikeda D, Daniel B, Ognibene G, Goffinet DR, Dirbas FM. Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Breast. 2016 Aug;28:178-83. doi: 10.1016/j.breast.2016.06.001. Epub 2016 Jun 17.
Other Identifiers
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IRB-13807
Identifier Type: -
Identifier Source: org_study_id
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