Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
2021년 1월 3일 업데이트: Shannon MacDonald, MD, Massachusetts General Hospital
Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation.
The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment).
Proton radiation delivers no dose beyond the region requiring treatment.
This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy.
In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
연구 개요
상세 설명
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
연구 유형
중재적
등록 (실제)
70
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
- Life expectancy > 12 months
Exclusion Criteria:
- Pregnant or breast-feeding
- Prior therapeutic radiation > 200 cGy
- History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
- Prior investigation chemotherapy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Proton Radiation
Radiation therapy with proton beam
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45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
기간: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
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From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Number of Participants With Acute Skin Toxicities
기간: From the start of treatment until 3 months after the end of treatment
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Summary of the number of participants with any grade acute skin toxicities.
Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment.
Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 3 months after the end of treatment
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Rate and Severity of Radiation Pneumonitis
기간: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
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The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
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Summary of Late Skin Toxicity
기간: From 3 months after the end of treatment up to 5 years
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A summary of the late skin toxicities experienced by participants.
The number of participants effected is shown for each toxicity experienced.
Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From 3 months after the end of treatment up to 5 years
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To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
기간: From the start of treatment until 5 years post treatment
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From the start of treatment until 5 years post treatment
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Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
기간: From the start of treatment until 5 years post treatment
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Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment.
Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 5 years post treatment
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The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
기간: From the start of treatment until 5 years post treatment
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From the start of treatment until 5 years post treatment
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The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
기간: Baseline and then 4 and 8 weeks post treatment
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The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram.
The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician.
Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion.
Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed.
Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.
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Baseline and then 4 and 8 weeks post treatment
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Progression Free Survival
기간: from the start of treatment until the time of disease progression, up to 5 years
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Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier.
Disease progression is defined as the appearance of one or more new lesions.
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from the start of treatment until the time of disease progression, up to 5 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Shannon M MacDonald, M.D., Massachusetts General Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 6월 1일
기본 완료 (실제)
2017년 4월 1일
연구 완료 (예상)
2022년 1월 1일
연구 등록 날짜
최초 제출
2011년 4월 20일
QC 기준을 충족하는 최초 제출
2011년 4월 20일
처음 게시됨 (추정)
2011년 4월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 3일
마지막으로 확인됨
2021년 1월 1일
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. .
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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University of UtahNational Cancer Institute (NCI)완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
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SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
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Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Society for Endocrinology초대로 등록
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Jonsson Comprehensive Cancer Center모병거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
Proton Radiation에 대한 임상 시험
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Sunnybrook Health Sciences CentreProstate Cancer Canada알려지지 않은
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Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTC아직 모집하지 않음
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University of Texas Southwestern Medical Center모집하지 않고 적극적으로
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Indiana UniversityIndiana University School of Medicine종료됨
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University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)모집하지 않고 적극적으로