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

NCT00337064 | Unknown Phase 1

• 1 other identifier: VCC0601
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Breast Cancer

Keywords

Breast cancer treatment; Partial breast radiation; Radiation Therapy; Adjuvant Treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Interventions

Radiation Therapy PROCEDURE

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lymphovascular invasion
• Positive nodes or tumor size greater than 2 cm
• Positive margins
• Age less than 65
• Patient is male

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Fletcher Allen Health Care, Radiation Oncology

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ruth Heimann, M.D., Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

802-847-3506; Ruth.Heimann@vtmednet.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: June 1, 2006
• Last Updated: June 15, 2006

Record last verified: 2006-05

Locations

US (1)