Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation
Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation: 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.
Surgery is the predominant treatment modality for patients with early-stage glottic carcinoma in China.
Patients with poorly-differentiated early-stage glottic carcinoma exhibit inferior local control after surgery compared with those with moderately-to-well-differentiated tumours.
Data from our previous retrospective study suggest that definitive radiotherapy/postoperative radiotherapy yields superior local control compared with surgery alone for poorly-differentiated early-stage glottic carcinoma.
We hypothesize that definitive radiotherapy and postoperative radiotherapy can improve local control rates in patients with poorly-differentiated early-stage glottic squamous cell carcinoma.
This study aims to conduct a multicenter, prospective, single-arm phase II clinical trial using intensity-modulated radiotherapy (IMRT) for patients with poorly-differentiated early-stage glottic laryngeal carcinoma, to preliminarily evaluate the impact of IMRT on local control rates and long-term survival outcomes in this patient population.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
38
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dongjun Dai, Doctor
- 電話番号：86-0571-86992821
- メール：daidongjunmed@zju.edu.cn
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310009
- 募集
- Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥18 years, any gender
- Histologically proven glottic squamous cell carcinoma
- T1 T2N0M0 glottic laryngeal carcinoma with poor differentiation (moderate poor differentiation counted as poor differentiation)
- Subjects undergoing curative intent surgery must be enrolled 4 8 weeks after operation.
- No prior chemoradiotherapy or antineoplastic therapy
- ECOG PS 0 1
- Written informed consent provided
Exclusion Criteria:
- Moderately or well differentiated tumours
- Prior chemotherapy or other antineoplastic agents
- Prior head and neck irradiation
- Previous participation in another clinical trial
- Severe allergic history including contrast media allergy
- Pregnancy or lactation
- Uncontrolled acute infection
- Drug/substance abuse, chronic heavy drinking, HIV infection
- Uncontrolled concomitant malignant disease
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Radiotherapy
intensity modulated radiotherapy (IMRT)
|
Post operative radiotherapy (CTV): CTV1 is routine postoperative laryngeal target covering whole larynx, piriform sinus, glosso epiglottic vallecula, paraglottic space, pre epiglottic space, thyroid cartilage down to inferior border of cricoid cartilage. Given higher lymphatic metastatic risk of poorly differentiated tumours, CTV2 delineates bilateral cervical nodal levels II III. PTV1/PTV2 are 3 mm isotropic expansions of CTV1/CTV2. Prescription: PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. Definitive radiotherapy targets: Additional GTV denotes macroscopic tumour identified by laryngoscopy and imaging. PGTV/PTV1/PTV2 are 3 mm isotropic expansions of GTV/CTV1/CTV2. Prescription: PGTV 66 Gy/30 fractions; PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
3-year local-regional failure-free survival (LRFS)
時間枠：From the date of enrollment to the date of local recurrence, , assessed up to 3 year.
|
3-year local-regional failure-free survival (LRFS): defined as the time from the date of enrollment 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 enrollment 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.
|
From the date of enrollment to the date of local recurrence, , assessed up to 3 year.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
5-year local-regional failure-free survival (LRFS)
時間枠：From the date of enrollment 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 enrollment 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 enrollment 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.
|
From the date of enrollment to the date of local recurrence, assessed up to 5 year.
|
|
5-year overall survival (OS)
時間枠：From the date of enrollment until the date of death 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 enrollment to the date of death due to any cause.
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From the date of enrollment until the date of death due to any cause, assessed up to 5 year.
|
|
5-year disease-free survival (DFS)
時間枠：Time from the date of enrollment to any evidence of tumour growth or death, assessed up to 5 year.
|
5-year disease-free survival (DFS): defined as the time from the date of enrollment 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 enrollment 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.
|
Time from the date of enrollment to any evidence of tumour growth or death, assessed up to 5 year.
|
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Adverse events
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月16日
一次修了 (推定)
2030年12月31日
研究の完了 (推定)
2031年12月31日
試験登録日
最初に提出
2026年8月18日
QC基準を満たした最初の提出物
2026年8月20日
最初の投稿 (実際)
2026年8月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月24日
QC基準を満たした最後の更新が送信されました
2026年8月20日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-1250
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