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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00185744
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
318
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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, 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 or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Study Start Date :
Sep 1, 2002
Anticipated Primary Completion Date :
Mar 1, 2029
Anticipated Study Completion Date :
Mar 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Accelerated Partial Breast Irradiation

lumpectomy with 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 Names:
  • MammoSite

    • Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
    5 day treatment

    Radiation: Stereotactic APBI
    4 day treatment
    Active Comparator: Standard Therapy

    lumpectomy and whole breast irradiation

    Procedure: Lumpectomy

    Radiation: Whole Breast Radiotherapy
    six and a half week treatment

    Outcome Measures

    Primary Outcome Measures

    1. In-breast tumor recurrence (IBTR) [20 years]

      Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Frederick M. Dirbas, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT00185744
    Other Study ID Numbers:
    • IRB-13807
    • 78466
    • BRSNSTU0003
    • IRB-13807
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Carcinoma, Ductal

    Study Results

    No Results Posted as of Feb 15, 2022