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Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation

20 augustus 2026 bijgewerkt door: Second Affiliated Hospital, Zhejiang University, School of Medicine

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

38

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Werving
        • Second Affiliated Hospital of Zhejiang University School of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Age ≥18 years, any gender
  2. Histologically proven glottic squamous cell carcinoma
  3. T1 T2N0M0 glottic laryngeal carcinoma with poor differentiation (moderate poor differentiation counted as poor differentiation)
  4. Subjects undergoing curative intent surgery must be enrolled 4 8 weeks after operation.
  5. No prior chemoradiotherapy or antineoplastic therapy
  6. ECOG PS 0 1
  7. Written informed consent provided

Exclusion Criteria:

  1. Moderately or well differentiated tumours
  2. Prior chemotherapy or other antineoplastic agents
  3. Prior head and neck irradiation
  4. Previous participation in another clinical trial
  5. Severe allergic history including contrast media allergy
  6. Pregnancy or lactation
  7. Uncontrolled acute infection
  8. Drug/substance abuse, chronic heavy drinking, HIV infection
  9. Uncontrolled concomitant malignant disease

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Radiotherapy
intensity modulated radiotherapy (IMRT)
Straling: Radiation: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
3-year local-regional failure-free survival (LRFS)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
5-year local-regional failure-free survival (LRFS)
Tijdsspanne: 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)
Tijdsspanne: From the date of enrollment until the date of death due to any cause, assessed up to 5 year.
Overall Survival(OS) is defined as the period from the date of enrollment to the date of death due to any cause.
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)
Tijdsspanne: 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.
Adverse events
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

16 september 2026

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

31 december 2031

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-1250

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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