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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by University of Vermont.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00337064
First received: June 13, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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 Intervention Phase
Stage I Breast Cancer
Procedure: Radiation Therapy
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: 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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

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

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

Estimated Enrollment: 75
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337064

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

Locations
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
Investigators
Principal Investigator: Ruth Heimann, M.D., Ph.D. University of Vermont
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00337064     History of Changes
Other Study ID Numbers: VCC0601
Study First Received: June 13, 2006
Last Updated: June 13, 2006
Health Authority: United States: Institutional Review Board

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014