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Phase I/II Trial to Evaluate Partial Breast Radiation to the Region of the Lumpectomy Cavity Using Intensity Modulated Radiation in Elderly Women With Breast Cancer


Phase 1/Phase 2
65 Years
N/A
Open (Enrolling)
Female
Stage I Breast Cancer

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Trial Information

Phase I/II Trial to Evaluate Partial Breast Radiation to the Region of the Lumpectomy Cavity Using Intensity Modulated Radiation in Elderly Women With Breast Cancer


Inclusion Criteria:



- Stage I ductal breast cancer,

- Status post lumpectomy/partial mastectomy and axillary dissection or sentinel lymph
node biopsy

- Age over 65

- Pathologically negative margins

- No lymphovascular invasion

- Able to begin radiation treatment 3-8 weeks post surgery, unless receiving
chemotherapy first

- Lumpectomy cavity is visible in CT

- Patient is female

Exclusion Criteria:

- Lymphovascular invasion

- Positive nodes or tumor size greater than 2 cm

- Positive margins

- Age less than 65

- Patient is male

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute sdie effects

Principal Investigator

Ruth Heimann, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont

Authority:

United States: Institutional Review Board

Study ID:

VCC0601

NCT ID:

NCT00337064

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Stage I Breast Cancer
  • Breast cancer treatment
  • Partial breast radiation
  • Radiation Therapy
  • Adjuvant Treatment
  • Breast Neoplasms

Name

Location
Fletcher Allen Health Care, Radiation Oncology Burlington, Vermont  05401