- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02112682
Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.
PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.
HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Almere, 네덜란드
- Flevoziekenhuis
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Amersfoort, 네덜란드
- Meander Medisch Centrum
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Amsterdam, 네덜란드
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Apeldoorn, 네덜란드
- Gelre Ziekenhuizen
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Arnhem, 네덜란드
- Rijnstate
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Breda, 네덜란드
- Amphia Ziekenhuis
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Delft, 네덜란드
- Reinier de Graaf
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Den Bosch, 네덜란드
- Jeroen Bosch ziekenhuis
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Den Haag, 네덜란드
- Haga ziekenhuis
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Den Haag, 네덜란드
- Bronovo / Medisch Centrum Haaglanden
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Deventer, 네덜란드
- Deventer Ziekenhuis
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Eindhoven, 네덜란드
- Catharina Ziekenhuis Eindhoven
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Enschede, 네덜란드
- Medisch Spectrum Twente
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Gouda, 네덜란드
- Groene Hart Ziekenhuis
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Groningen, 네덜란드
- Martini Ziekenhuis
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Groningen, 네덜란드
- UMC Groningen
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Heerlen, 네덜란드
- Zuyderland Medisch Centrum
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Hilversum, 네덜란드
- Tergooi
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Leiden, 네덜란드
- Alrijne Ziekenhuis
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Nieuwegein, 네덜란드
- St. Antonius Ziekenhuis
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Nijmegen, 네덜란드
- Radboud University Medical Center
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Nijmegen, 네덜란드
- Canisius-Wilhelmina Ziekenhuis
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Roermond, 네덜란드
- Laurentius Ziekenhuis
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Sittard, 네덜란드
- Zuyderland Medisch Centrum
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Sneek, 네덜란드
- Antonius Ziekenhuis
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Tiel, 네덜란드
- Rivierenland
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Tilburg, 네덜란드
- St. Elisabeth Ziekenhuis
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Utrecht, 네덜란드
- Diakonessenhuis Utrecht
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Veldhoven, 네덜란드
- Maxima Medisch Centrum
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Zwolle, 네덜란드
- Isala Klinieken
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Limburg
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Maastricht, Limburg, 네덜란드, 6202 AZ
- Maastricht University Medical Centre+
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female
- Aged 18 years or older
- Pathologically confirmed invasive unilateral breast carcinoma
- A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
- Will be or is treated with mastectomy
- Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
- Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
- pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
- Written informed consent
Exclusion Criteria:
- Clinically node positive pre-operative
- Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- Solitary parasternal sentinel lymph node metastasis (pN1b)
- Bilateral breast cancer
- Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
- Evidence of metastatic disease
- History of invasive breast cancer
- Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
- Pregnant or nursing
- Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
- Unable or unwilling to give informed consent
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 |
---|---|
활성 비교기: Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
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Completion axillary treatment according to the Dutch breast cancer guideline
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간섭 없음: No completion axillary treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Regional recurrence rate
기간: up to ten years
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Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
|
up to ten years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marjolein L Smidt, MD, PhD, Maastricht University Medical Centre+, Maastricht, the Netherlands
- 수석 연구원: Hans JW de Wilt, MD, PhD, Radboud University Medical Centre, Nijmegen, The Netherlands
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- BOOG 2013-07
- KWF UM 2013-5920 (기타 보조금/기금 번호: Dutch Cancer Society (in Dutch: KWF Kankerbestrijding))
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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University of Alabama at Birmingham모병
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