Status:
ACTIVE_NOT_RECRUITING
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Lead Sponsor:
Stanford University
Conditions:
Breast Cancer
Carcinoma, Ductal
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ
- Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
- Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Exclusion
- Men
- Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years
- Pregnant women
- Immunocompromised
- Poorly controlled insulin dependent diabetes
- Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
- Breast cancer that involves skin or chest wall
- Multifocal or Multicentric breast cancer
- Invasive lobular carcinoma
- Diffuse microcalcifications on mammography
- Invasive carcinoma with extensive intraductal component (EIC)
- Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
- Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
- Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
- Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2029
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00185744
Start Date
September 1 2002
End Date
March 1 2029
Last Update
March 20 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305