Bruce Daniel
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Device: Accelerated Partial Breast Irradiation
- Procedure: Lumpectomy
Phase:
N/AEligibility
Ages Eligible for Study:
40 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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)
Additional Study Details
Official Title:
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast CancerAnticipated start date:
9/24/2002Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Determination of whether accelerated radiotherapy or stereotactic APBI is a feasible and safe alternative to whole breast radiotherapy.
Total Number to be Enrolled:
400Total Number to be Enrolled at Stanford:
400More Information
Secondary ID(s):
- 78466
- BRSNSTU0003
- NCT00185744
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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