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Partial Breast Radiation to the Lumpectomy Cavity With IMRT in Elderly Women

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ClinicalTrials.gov Identifier: NCT00337064
Recruitment Status : Unknown
Verified May 2006 by University of Vermont.
Recruitment status was:  Recruiting
First Posted : June 15, 2006
Last Update Posted : June 15, 2006
Information provided by:
University of Vermont

Brief Summary:

The standard treatment for women with invasive breast cancer is local excision follow by whole breast radiation. The local recurrence rates are low, side effects are low, and the cosmetic outcome is excellent. The treatments, however, need to be given daily for 5 1/2 to 6 1/2 weeks, making the treatment difficult, particularly for the elderly and for women who need to travel long distances for the therapy. The goal of this study is to determine the toxicity and efficacy of giving the radiation in a shorter time, using higher daily doses of radiation.

The risk of recurrence in the elderly population is lower, and since majority of recurrences occur close to the area where the tumor previously was, it is hypothesized that radiation to that area of the breast would be sufficient to obtain low risk of recurrence. When a smaller volume of tissue is treated, more radiation can be given daily, and therefore the treatment can be shortened. The risk of side effects increases as the dose per daily treatment increases. Therefore, the goal is to study the short term side effects, long term side effects, and cosmetic outcome of daily radiation using higher daily doses for shorter period of time. We will also follow the recurrence rate. Because less of the breast tissue will be treated, there may be a small increased risk of recurrence. Because the higher fraction size can result in more side effects we will be using intensity modulated radiation (IMRT). IMRT is the most advanced individually tailored radiation treatment technique that results in the least amount of side effects. It allows tight monitoring of the dose in the untreated breast.

Seventy five women diagnosed with stage I breast cancer will participate. Participants must have a lumpectomy, clear margins and no lymphovascular invasion to be eligible. A treatment planning CT scan will be obtained. If the lumpectomy cavity can be clearly delineated, an IMRT plan will be generated with predefined strict dose requirement criteria. The patients will be treated once daily, 5 days a week, for a total of 10 treatments (instead of standard 28-33). The patients will be evaluated for toxicity weekly during the treatment, and weekly for additional 4 weeks. At each of these evaluations, they will fill out a short 10 minute questionnaire detailing their side effects. Follow-up will continue every 3 months for 3 years, and every 6 months for 2 more years. At each of these follow-ups a short questionnaire will be filled out by the patients detailing any toxicity, as well as their perception of the cosmetic outcome. A cosmesis questionnaire will be also be filled out by the evaluating physician before radiation, at 6, 12, 18, and 24 months, and yearly for 3 more years. A total of 5 years of follow-up is planned. Participants will also have the option of consenting to the photograph portion of the study. Those who do will have photographs taken of their breasts (excluding faces) at the time they complete the cosmetic questionnaire, to evaluate the cosmetic outcome.

Condition or disease Intervention/treatment Phase
Stage I Breast Cancer Procedure: Radiation Therapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Acute sdie effects
  2. Percent of times that the target definition on planning CT is attained
  3. Percent of times that the treatment is within the prescription goals

Secondary Outcome Measures :
  1. Set up variations
  2. Subacute and long-term side effects
  3. Cosmetic outcome
  4. Percent experiencing local failure, time to recurrence and percent who can be retreated with radiation following recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337064

Contact: Ruth Heimann, M.D., Ph.D. 802-847-3506 Ruth.Heimann@vtmednet.org

United States, Vermont
Fletcher Allen Health Care, Radiation Oncology Recruiting
Burlington, Vermont, United States, 05401
Contact: Ruth Heimann, M.D., Ph.D.    802-847-3506    Ruth.Heimann@vtmednet.org   
Principal Investigator: Ruth Heimann, M.D., Ph.D.         
Sponsors and Collaborators
University of Vermont
Principal Investigator: Ruth Heimann, M.D., Ph.D. University of Vermont

ClinicalTrials.gov Identifier: NCT00337064     History of Changes
Other Study ID Numbers: VCC0601
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: June 15, 2006
Last Verified: May 2006

Keywords provided by University of Vermont:
Breast cancer treatment
Partial breast radiation
Radiation Therapy
Adjuvant Treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases