Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure
2026년 8월 20일 업데이트: Second Affiliated Hospital, Zhejiang University, School of Medicine
Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure: A Prospective, Multicenter, Phase II Clinical Trial
There remains no uniform treatment modality for glottic laryngeal carcinoma.
Current clinical guidelines broadly recommend surgery or radiotherapy as single modality treatment for early stage glottic laryngeal carcinoma.
Glottic carcinoma with anterior commissure invasion is linked to inferior local control; both definitive radiotherapy alone or transoral laser microsurgery (TLM) may confer a higher risk of local recurrence compared with other glottic carcinomas.
We hypothesize that postoperative radiotherapy can act as an effective adjunct to surgery and reduce recurrence rates in patients with glottic carcinoma involving the anterior commissure.
This study aims to conduct a multicenter, prospective, single arm phase II clinical trial of intensity modulated radiotherapy (IMRT) for postoperative patients with early stage glottic laryngeal carcinoma and anterior commissure involvement, to preliminarily evaluate the effect of IMRT on local control rates and long term survival outcomes in this patient population.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
38
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dongjun Dai, Doctor
- 전화번호: 86-0571-86992821
- 이메일: daidongjunmed@zju.edu.cn
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- 모병
- Second Affiliated Hospital of Zhejiang University School of Medicine
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Aged 18 years or older, regardless of gender;
- Pathologically confirmed glottic squamous cell carcinoma;
- T1-T2N0M0 glottic laryngeal carcinoma with anterior commissure involvement;
- Patients who have undergone curative intent surgery for glottic carcinoma with negative surgical margins, within 4-8 weeks post operation;
- No prior radiotherapy, chemotherapy or other anti neoplastic agent treatment;
- ECOG performance status of 0 or 1;
- Signed informed consent form.
Exclusion Criteria:
- Patients without anterior commissure involvement;
- Prior chemotherapy or treatment with other anti neoplastic agents;
- Prior history of head and neck radiotherapy;
- Prior participation in other clinical trials;
- Patients with severe allergy history or allergic diathesis, e.g., contrast medium allergy;
- Pregnant or lactating women;
- Patients with uncontrolled acute infection;
- Patients with drug addiction, substance abuse, chronic heavy alcohol consumption, or human immunodeficiency virus (HIV) infection;
- Patients with other uncontrolled concurrent malignancies.
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: Postoperative radiotherapy
intensity modulated radiotherapy (IMRT)
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Postoperative radiotherapy clinical target volume (CTV) design: The conventional postoperative laryngeal radiotherapy target is defined as CTV1, which encompasses the entire laryngeal structure, piriform sinus, gloss-epiglottic vallecula, paraglottic space, pre-epiglottic space, thyroid cartilage, and extends to the inferior border of the cricoid cartilage. For T2 tumours, CTV2 is delineated to include bilateral cervical lymph node regions II-III. PTV1 and PTV2 are defined as the regions expanded by 3 mm outward from CTV1 and CTV2, respectively. The prescribed dose for PTV1 is 60 Gy in 30 fractions (60 Gy/30F), and the prescribed dose for PTV2 is 54 Gy in 30 fractions (54 Gy/30F). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-year local-regional failure-free survival (LRFS)
기간: From the date of surgery to the date of local recurrence, , assessed up to 3 year.
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3-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues.
The index date for recurrence is the date when a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death.
For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
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From the date of surgery to the date of local recurrence, , assessed up to 3 year.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse events
기간: From enrollment to the end of treatment at 5 years.
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The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
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From enrollment to the end of treatment at 5 years.
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5-year local-regional failure-free survival (LRFS)
기간: From the date of surgery to the date of local recurrence, assessed up to 5 year.
|
5-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues.
The index date for recurrence is the date when a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death.
For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
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From the date of surgery to the date of local recurrence, assessed up to 5 year.
|
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5-year overall survival (OS)
기간: From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
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Overall Survival(OS) is defined as the period from the date of surgery to the date of death due to any cause.
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From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
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5-year disease-free survival (DFS)
기간: Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
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5-year disease-free survival (DFS): defined as the time from the date of surgery during which the patient remains alive without evidence of tumour growth.
Recurrence is defined as the emergence of new lesions, including recurrence of the primary lesion and perilesional tissues, cervical lymph-node metastasis, and distant metastasis.
The index date for recurrence is the date on which a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, DFS is calculated from the date of surgery to the date of death.
For patients with no documented disease recurrence or death at the time of analysis (i.e., disease-free survivors), the time of the last efficacy assessment will serve as the endpoint.
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Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
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여기에서 이 연구와 관련된 사람과 조직을 찾을 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 (추정된)
2026년 9월 16일
기본 완료 (추정된)
2031년 12월 31일
연구 완료 (추정된)
2031년 12월 31일
연구 등록 날짜
최초 제출
2026년 8월 18일
QC 기준을 충족하는 최초 제출
2026년 8월 20일
처음 게시됨 (실제)
2026년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 20일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-0861
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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