Text Size

Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00977275
First received: September 11, 2009
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.


Condition Intervention Phase
Breast Cancer
 Radiation: Interstitial Implant Brachytherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: June 1997
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Interstitial Implant Brachytherapy
    Via tubes placed at the time of wide local excision delivered over 5 days
Detailed Description:
  • When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes will remain in place for 7-9 days following the surgery.
  • The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
  • Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor < 2cm, clinically negative nodes)
  • Location of primary tumor is not immediately adjacent to the nipple of chest wall
  • No evidence of two or more separate tumors within the breast
  • All histologic types and pathologic grades of primary tumor
  • No extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
  • No lymphatic or vascular invasion
  • Lymph node staging by sentinel node excision or axillary dissection confirms node negative status (If node positive, implant is used to deliver boost to tumor bed)
  • Assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
  • 18 years of age or older

Exclusion Criteria:

  • Tumor is too close to the chest wall to allow placement of catheters
  • Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977275

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Alphonse Taghian, MD, PhD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Alphonse Taghian, MD, PhD, Chief Breast Radiation Oncology, MGH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00977275     History of Changes
Other Study ID Numbers: 97-585
Study First Received: September 11, 2009
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
early stage invasive breast cancer

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

ClinicalTrials.gov processed this record on May 23, 2013