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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00185744
First received: September 12, 2005
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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.


Condition Intervention
Breast Cancer
Carcinoma, Ductal
 Radiation: Intra-Operative Radiotherapy (IORT)
Procedure: Lumpectomy
Radiation: Whole Breast Radiotherapy
Radiation: Intracavitary Brachytherapy
Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
Radiation: Stereotactic APBI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Determination of whether accelerated radiotherapy or stereotactic APBI is a feasible and safe alternative to whole breast radiotherapy.

Estimated Enrollment: 400
Study Start Date: September 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated Partial Breast Irradiation Radiation: Intra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy
Procedure: Lumpectomy Radiation: Intracavitary Brachytherapy
5 day treatment
Other Name: MammoSite
Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
Radiation: Stereotactic APBI
4 day treatment
Active Comparator: Standard Therapy Procedure: Lumpectomy Radiation: Whole Breast Radiotherapy
six and a half week treatment

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185744

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Frederick M. Dirbas Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00185744     History of Changes
Other Study ID Numbers: BRSNSTU0003, 78466, BRSNSTU0003, 13807
Study First Received: September 12, 2005
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on March 06, 2013