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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Not Recruiting
Trial ID: NCT00185744
Purpose
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity
plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite
device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a
feasible and safe alternative to a six and a half week course of whole breast radiotherapy.
The study will measure both short and long-term complications of radiation treatment, short
and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional
recurrences, distant metastases, and overall survival.
Official Title
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Stanford Investigator(s)
Frederick M. Dirbas, MD
Associate Professor of Surgery (General Surgery)
Kathleen Horst, MD
Professor of Radiation Oncology (Radiation Therapy)
Bruce Daniel
Professor of Radiology (Body Imaging) and, by courtesy, of Bioengineering
Debra M. Ikeda, M.D.
Professor of Radiology (Breast Imaging), Emerita
Eligibility
Inclusion Criteria:
1. Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
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:
1. Men
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)
Intervention(s):
procedure: Lumpectomy
radiation: Intra-Operative Radiotherapy (IORT)
radiation: Whole Breast Radiotherapy
radiation: Intracavitary Brachytherapy
radiation: Accelerated External Beam 3-D Conformal Radiotherapy
radiation: Stereotactic APBI
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sally Bobo
6507361472