Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Trial ID or NCT#

NCT00185744

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 40 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer3. Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Exclusion Criteria:
  1. 1. Men2. Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years3. Pregnant women4. Immunocompromised5. Poorly controlled insulin dependent diabetes6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma7. Breast cancer that involves skin or chest wall8. Multifocal or Multicentric breast cancer9. Invasive lobular carcinoma10. Diffuse microcalcifications on mammography11. Invasive carcinoma with extensive intraductal component (EIC)12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy14. 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)
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Investigator(s)

Frederick M. Dirbas, MD
Frederick M. Dirbas, MD
Breast specialist, Breast surgeon, Surgical oncologist
Associate Professor of Surgery (General Surgery)
Kathleen Horst, MD
Kathleen Horst, MD
Radiation oncologist
Professor of Radiation Oncology (Radiation Therapy)
Richard Sibley
Bruce Daniel
Bruce Daniel
Radiologist
Professor of Radiology (Body Imaging) and, by courtesy, of Bioengineering
Debra M. Ikeda, M.D.
Debra M. Ikeda, M.D.
Radiologist
Professor of Radiology (Breast Imaging), Emerita

Contact us to find out if this trial is right for you.

Contact

Sally Bobo
6507361472

View on ClinicalTrials.gov