RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine • ClinicalTrials.gov ID: NCT07781098

Registry updated: 2026-08-24

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Radiation: intensity modulated radiotherapy (IMRT) (Radiation)
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.

Eligibility criteria

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

Conditions

Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation

Locations

Second Affiliated Hospital Of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment