- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00212121
Radiation Dose Intensity Study in Breast Cancer in Young Women
Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
연구 개요
상세 설명
Title of the study:
Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed.
Background and aim of the study:
Several studies showed that breast conserving therapy (BCT) yields similar survival rates as mastectomy. BCT consists of lumpectomy followed by whole breast radiotherapy (WBRT). Three studies showed that an additional dose to the tumor bed, after 50 Gy WBRT, reduces the local recurrence rate (LRR). The largest of these 3 studies was a recent EORTC trial, which also showed that young age was an independent risk factor for LR after BCT.
In patients < 51 years of age, the LR rate was reduced with 50% after a 66 Gy dose to the tumor bed, compared to 50 Gy (5-year LRR 12% vs 5.9%, p < 0.02). However, the LRR in young women was still quite high (> 1% per year). Therefore the first aim of the study is to investigate whether an additional boost dose to the tumorbed (26 Gy) reduces the LRR further. Therefore, we will compare the effect of a low boost dose (16 Gy) with the effect of a high boost dose (26 Gy) on the LRR, but also on the cosmetic outcome.
The second, very important aim of this study is to investigate whether we can find genetic or protein profiles that correlate with LRR, lymph node metastases, distant metastases, survival, radiosensitivity, and age. For this purpose we will obtain frozen tumor material and blood samples of as many patients as possible.
Population, study design, intervention:
Patients younger than 51 years of age, with stage T1-2N01-2aM0 breast cancer, and where the tumor can be locally excised with acceptable cosmetic result, will be randomized between a 16 Gy boost dose to the tumorbed and a 26 Gy boost dose to the tumor bed, after 50 Gy WBRT. Patients will be stratified based on age, tumor size, lymph node metastases, estrogen receptor status, interstitial or external boost irradiation, and institution. In principle frozen tumor samples and blood samples will be stored of each patient.
Endpoints and statistics:
The primary endpoint is LRR are 10 years. The secondary endpoint is cosmetic result, which will be quantified using digitized color photographs. In addition, patients will be asked to give their opinion about the cosmetic result using standardized questionnaires.
To find an increase in the local control rate of 88% to 93% at 10 year, with a power of 80% and a significance level of 5%, 580 patients will be included in each treatment arm.
Side studies:
An extremely important aspect of this trial is to obtain fresh tumor material and blood samples. These will be used to determine genetic and protein profiles aimed at finding subgroups based on these profiles, which may take more or less advantage of the additional radiation treatment.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1066 CX
- The Netherlands Cancer Institute
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Besancon, 프랑스, 25030
- Hôpital J-Minjoz
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Bordeaux, 프랑스, 33076
- Institut Bergonie
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Creteil, 프랑스, 94000
- CHU Henri Mondor
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Lille, 프랑스, 59000
- Centre Oscar Lambret
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Marseille, 프랑스, 13009
- Institut Paoli Calmettes
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Montpellier cedex 5, 프랑스, 34298
- Centre Val D'Aurelle
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Nice, 프랑스, 06189
- Centre Antoine Lacassagne
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Paris, 프랑스, 75010
- Hopital Saint Louis
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Paris, 프랑스, 75005
- Institut Curie
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Pierre Benite Cedex, 프랑스, 69495
- Centre Hospitalier Lyon Sud
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Rennes, 프랑스, 35000
- Centre Eugène Marquis
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Rouen, 프랑스, 76000
- Centre Henri Becquerel
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Saint Cloud, 프랑스, 92210
- Centre René Huguenin
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Saint Herblain Cedex, 프랑스, 44805
- Centre Rene Gauducheau
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Strasbourg, 프랑스, 67085
- Centre Paul Strauss
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Tours, 프랑스, 37000
- CHU de Tours
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Villejuif, 프랑스, 94800
- Institut Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Age 50 years or younger.
- Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
- Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
- Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
- Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
- Breast cancer stage: pT1-2pN0-2a M0.
- No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
- In cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy.
- In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy.
- In cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
- No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- ECOG performance scale 2 or less.
Exclusion criteria:
- Residual microcalcifications on mammogram.
- All histological types of malignancies other than invasive adenocarcinoma.
- In situ carcinoma of the breast, without invasive tumor.
- Concurrent pregnancy.
- Multicentric tumors, and multifocal. tumors excised using multiple excisions * Invasive breast cancer in both breasts.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 1
low dose boost (16 Gy)
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high dose boost
low dose versus high dose
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실험적: 2
high boost (26 Gy)
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high dose boost
low dose versus high dose
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Local control at 10 yr
기간: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
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at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
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2차 결과 측정
결과 측정 |
기간 |
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Cosmetic outcome
기간: prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
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prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Liesbeth Boersma, MD, MAASTRO Clinic, Heerlen
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
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