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Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation: A Prospective Multicenter Phase II Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Second Affiliated Hospital Of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Dongjun Dai, Doctor
daidongjunmed@zju.edu.cn
86-0571-86992821
Time Frame
Start Date: 2026-09-16
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 38
Treatments
Experimental: Radiotherapy
intensity modulated radiotherapy (IMRT)
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, Zhejiang University, School of Medicine

This content was sourced from clinicaltrials.gov