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.

Study Overview

• Status: Recruiting
• Conditions: Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation
• Intervention / Treatment: Radiation: Radiation: intensity modulated radiotherapy (IMRT)

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongjun Dai, Doctor; Phone Number: 86-0571-86992821; Email: daidongjunmed@zju.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiotherapy; intensity modulated radiotherapy (IMRT)

Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year local-regional failure-free survival (LRFS)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year local-regional failure-free survival (LRFS)	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)	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)	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	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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy, Intensity-Modulated
• Other Study ID Numbers: 2026-1250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No