- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00337064
Partial Breast Radiation to the Lumpectomy Cavity With IMRT in Elderly Women
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
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.
연구 개요
연구 유형
등록
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Vermont
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Burlington, Vermont, 미국, 05401
- 모병
- Fletcher Allen Health Care, Radiation Oncology
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연락하다:
- Ruth Heimann, M.D., Ph.D.
- 전화번호: 802-847-3506
- 이메일: Ruth.Heimann@vtmednet.org
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수석 연구원:
- Ruth Heimann, M.D., Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Acute sdie effects
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Percent of times that the target definition on planning CT is attained
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Percent of times that the treatment is within the prescription goals
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2차 결과 측정
결과 측정 |
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미용 결과
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Set up variations
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Subacute and long-term side effects
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Percent experiencing local failure, time to recurrence and percent who can be retreated with radiation following recurrence
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ruth Heimann, M.D., Ph.D., University of Vermont
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
방사선 요법에 대한 임상 시험
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