Selective Neck Dissection Under Multimodal Assessment for N3 Nasopharyngeal Carcinoma After Radiotherapy
A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy
The goal of this phase I clinical trial is to evaluate the safety and feasibility of a multimodal evaluation-guided surveillance-intervention strategy in patients with newly diagnosed N3 nasopharyngeal carcinoma. The main questions it aims to answer are:
- Is the multimodal evaluation-guided surveillance-intervention approach safe for patients?
- Is this approach feasible for identifying and managing residual cervical lymph nodes after radiotherapy?
Participants receive standard chemoradiotherapy. After treatment, they undergo follow-up evaluation using clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention undergo selective neck dissection.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph node disease after radiotherapy. Conventional imaging may have difficulty distinguishing viable residual tumor from post-radiotherapy edema, fibrosis, scarring, or inflammation. Contrast-enhanced ultrasound (CEUS) provides information on lymph node microvascular perfusion and may complement routine follow-up assessment. For patients with suspected residual cervical lymph node disease, selective neck dissection may be considered as a salvage treatment option.
This prospective, single-center, single-arm phase I study enrolled patients with pathologically confirmed N3 nasopharyngeal carcinoma. After completion of radiotherapy, participants underwent multimodal cervical lymph node follow-up evaluation, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and CEUS. During follow-up, participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention underwent selective neck dissection. Participants were followed for adverse events, postoperative complications, disease progression, locoregional recurrence, distant metastasis, and survival outcomes. The main purpose of this study is to evaluate the safety and feasibility of this multimodal evaluation-guided surveillance-intervention strategy.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- West China Hospital of Stomatology, Sichuan University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18 to 70 years.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- Tumor staged as TanyN3M0 according to the 8th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- ECOG performance status 0-1.
- No previous neck dissection.
- Adequate hematologic, hepatic, and renal function, defined as: white blood cell count ≥4.0 × 10^9/L, absolute neutrophil count ≥2.0 × 10^9/L, hemoglobin ≥90 g/L, platelet count ≥100 × 10^9/L, aspartate aminotransferase and alanine aminotransferase ≤2.5 × the upper limit of normal, and creatinine clearance ≥60 mL/min
- Written informed consent provided prior to study enrollment
Exclusion Criteria:
- Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
- Pregnancy or breastfeeding
- Severe concomitant disease that may, in the investigator's judgment, pose an unacceptable risk or compromise study compliance, including severe cardiac disease, severe pulmonary dysfunction, significant renal disease, or severe psychiatric illness.
- History of another invasive malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder tumors (Ta, Tis, or T1).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Multimodal Evaluation-Guided Surveillance-Intervention Strategy
Participants underwent multimodal follow-up evaluation after radiotherapy, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound.
Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention underwent selective neck dissection.
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All participants underwent multimodal follow-up evaluation after radiotherapy.
Selective neck dissection was performed only in participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered to have an indication for surgical intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events
기간: From enrollment through post-radiotherapy follow-up, up to 36 months
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Treatment-emergent adverse events are defined as adverse events occurring after the start of study intervention.
Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
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From enrollment through post-radiotherapy follow-up, up to 36 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-Free Survival
기간: From enrollment to disease progression, death, or last follow-up, up to 36 months.
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Progression-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, or death from any cause, whichever occurs first.
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From enrollment to disease progression, death, or last follow-up, up to 36 months.
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Distant Metastasis-Free Survival
기간: From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
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Distant metastasis-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
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From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
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Overall Survival
기간: From enrollment to death or last follow-up, up to 36 months.
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Overall survival is defined as the time from enrollment to death from any cause.
Participants alive at the last follow-up will be censored.
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From enrollment to death or last follow-up, up to 36 months.
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Completion Rate of Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease
기간: From enrollment to completion of indicated selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
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The completion rate is defined as the proportion of participants who undergo selective neck dissection as planned among participants with suspected residual cervical nodal disease identified by multimodal evaluation.
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From enrollment to completion of indicated selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- WCHSIRB-CT-2022-267-R1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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