Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive NSCLC
A Multicenter Prospective Randomized Controlled Trial of Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive Non-Small Cell Lung Cancer
연구 개요
상세 설명
Station 4L lymph nodes are located in a technically challenging area near the aortic arch, left pulmonary artery, thoracic duct, and left recurrent laryngeal nerve. Dissection may improve nodal staging but may also increase operative complexity and complications. This study will evaluate whether station 4L dissection can be omitted without compromising long-term outcomes in patients with early-stage left-sided invasive non-small cell lung cancer.
Eligible participants will undergo complete resection by segmentectomy or lobectomy and systematic mediastinal lymph node dissection. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer, participants will be randomized in a 1:1 ratio to station 4L lymph node dissection or no station 4L dissection. Randomization is stratified by tumor lobe. The planned enrollment is 384 participants, including 258 with left upper lobe tumors and 126 with left lower lobe tumors.
Participants will be followed every 6 months for 3 years after surgery. The primary comparison is 3-year disease-free survival. Secondary assessments include 3-year overall survival, surgery-related complications within 30 days, all-cause mortality within 90 days, and the frequency of station 4L nodal metastasis among participants assigned to station 4L dissection.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Xuhui
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Shanghai, Xuhui, 중국, 200000
- 모병
- Fudan University Shanghai Cancer Center
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연락하다:
- Yang Zhang, MD
- 전화번호: 86-18717722753
- 이메일: 16301050173@fudan.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 to 75 years.
- A single solid pulmonary nodule (consolidation-to-tumor ratio of 1.0) located in the left lung.
- Resectable clinical stage I (T1-T2aN0M0) non-small cell lung cancer, with a maximum tumor diameter of 4 cm or less, evaluated by positron emission tomography/computed tomography.
- Planned complete lung resection by segmentectomy or lobectomy with systematic mediastinal lymph node dissection.
- Intraoperative frozen-section pathological confirmation of invasive non-small cell lung cancer before randomization.
- Able to provide written informed consent and willing to complete the protocol-specified follow-up.
Exclusion Criteria:
- Intraoperative or postoperative pathology indicates noninvasive non-small cell lung cancer.
- Surgical procedure other than segmentectomy or lobectomy.
- Incomplete tumor resection or residual tumor.
- History of another malignant tumor.
- History of previous lung surgery.
- Previous radiotherapy or chemotherapy for the current lung cancer.
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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실험적: Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes.
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During complete lung resection and systematic mediastinal lymph node dissection, all lymphatic and fatty tissue in the station 4L region is surgically removed and submitted for pathological examination.
Other mediastinal stations are dissected according to the study protocol in both arms.
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간섭 없음: No Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, but station 4L lymph nodes are not surgically removed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-Year Disease-Free Survival
기간: From enrollment to 3 years
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Proportion of participants alive without disease recurrence.
A disease-free survival event is the first documented recurrence of non-small cell lung cancer or death from any cause.
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From enrollment to 3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-Year Overall Survival
기간: From enrollment to 3 years
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Proportion of participants alive 3 years after enrollment.
Death from any cause is counted as an event.
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From enrollment to 3 years
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30-Day Surgery-Related Complication Rate
기간: From surgery through postoperative day 30
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Proportion of participants with at least one surgery-related complication, graded according to Common Terminology Criteria for Adverse Events version 3.0.
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From surgery through postoperative day 30
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90-Day All-Cause Mortality
기간: From surgery through postoperative day 90
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Proportion of participants who die from any cause within 90 days after surgery.
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From surgery through postoperative day 90
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Station 4L Lymph Node Metastasis Rate
기간: At postoperative pathological assessment, up to 30 days after surgery
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Among participants assigned to station 4L lymph node dissection, the proportion with pathologically confirmed metastasis in resected station 4L lymph nodes.
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At postoperative pathological assessment, up to 30 days after surgery
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Haiquan Chen, Fudan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ECTOP-1034
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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