Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure
20 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
38
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dongjun Dai, Doctor
- Numéro de téléphone: 86-0571-86992821
- E-mail: daidongjunmed@zju.edu.cn
Lieux d'étude
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chine, 310009
- Recrutement
- Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Postoperative radiotherapy
intensity modulated radiotherapy (IMRT)
|
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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
3-year local-regional failure-free survival (LRFS)
Délai: From the date of surgery 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 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.
|
From the date of surgery to the date of local recurrence, , assessed up to 3 year.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adverse events
Délai: From enrollment to the end of treatment at 5 years.
|
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).
|
From enrollment to the end of treatment at 5 years.
|
|
5-year local-regional failure-free survival (LRFS)
Délai: 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.
|
From the date of surgery to the date of local recurrence, assessed up to 5 year.
|
|
5-year overall survival (OS)
Délai: From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
|
Overall Survival(OS) is defined as the period from the date of surgery to the date of death due to any cause.
|
From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
|
|
5-year disease-free survival (DFS)
Délai: Time from the date of surgery 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 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.
|
Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
16 septembre 2026
Achèvement primaire (Estimé)
31 décembre 2031
Achèvement de l'étude (Estimé)
31 décembre 2031
Dates d'inscription aux études
Première soumission
18 août 2026
Première soumission répondant aux critères de contrôle qualité
20 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0861
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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