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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00185744
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

September 12, 2005
September 16, 2005
December 12, 2016
September 2002
March 2029   (Final data collection date for primary outcome measure)
In-breast tumor recurrence (IBTR) [ Time Frame: 20 years ]
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
Not Provided
Complete list of historical versions of study NCT00185744 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Carcinoma, Ductal
  • Radiation: Intra-Operative Radiotherapy (IORT)
    single dose in the operating room after lumpectomy
  • Procedure: Lumpectomy
  • Radiation: Whole Breast Radiotherapy
    six and a half week treatment
  • 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
  • Experimental: Accelerated Partial Breast Irradiation
    lumpectomy with accelerated partial breast irradiation
    Interventions:
    • Radiation: Intra-Operative Radiotherapy (IORT)
    • Procedure: Lumpectomy
    • Radiation: Intracavitary Brachytherapy
    • Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
    • Radiation: Stereotactic APBI
  • Active Comparator: Standard Therapy
    lumpectomy and whole breast irradiation
    Interventions:
    • Procedure: Lumpectomy
    • Radiation: Whole Breast Radiotherapy
Horst KC, Fasola C, Ikeda D, Daniel B, Ognibene G, Goffinet DR, Dirbas FM. Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Breast. 2016 Aug;28:178-83. doi: 10.1016/j.breast.2016.06.001. Epub 2016 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
50
March 2029
March 2029   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00185744
BRSNSTU0003
78466 ( Other Identifier: Old IRB Protocol ID )
BRSNSTU0003 ( Other Identifier: OnCore )
IRB-13807 ( Other Identifier: Stanford IRB )
Yes
Not Provided
Plan to Share IPD: No
Stanford University
Stanford University
Not Provided
Principal Investigator: Frederick M. Dirbas Stanford University
Stanford University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP