Status:

COMPLETED

Study of Prone Accelerated Breast And Nodal IMRT

Lead Sponsor:

NYU Langone Health

Conditions:

Lymphedema

Eligibility:

FEMALE

36-90 years

Phase:

NA

Brief Summary

Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone...

Detailed Description

A recent Cochrane Collaboration Intervention Review has addressed the effects of altered fractionation size on women with early breast cancer who have undergone breast conservation surgery. Analysis o...

Eligibility Criteria

Inclusion

  • Pre- or post-menopausal women with stage II - III breast cancer (AJCC 2002)
  • Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
  • Status post segmental mastectomy or mastectomy and axillary node dissection with removal of at least 8 nodes
  • One to 5 involved lymph nodes identified at axillary staging
  • At least 2 weeks from last chemotherapy or before chemotherapy
  • No more than sixty days from final surgery to simulation if no systemic therapy (includes chemotherapy and Hormonal therapy) is given
  • Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion

  • Previous radiation therapy to the ipsilateral breast
  • More than 5 involved nodes identified at axillary staging
  • Current treatment for active connective tissue disorders, such as lupus or scleroderma
  • Pregnant or lactating women
  • Less than 35 years old

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 12 2021

Estimated Enrollment :

97 Patients enrolled

Trial Details

Trial ID

NCT02308488

Start Date

September 1 2009

End Date

October 12 2021

Last Update

April 27 2023

Active Locations (1)

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Laura and Issac Perlmutter Cancer Center

New York, New York, United States, 10016