Radiotherapy Approach for Poorly Differentiated Early Glottic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, single-arm phase II study assesses intensity-modulated radiotherapy (IMRT) as a curative treatment for adults with T1–T2N0M0 glottic squamous cell carcinoma with poor differentiation. Eligible patients may receive IMRT as definitive therapy or as postoperative radiotherapy after surgery, aiming to improve local control compared with historical expectations for poorly differentiated tumors. The study excludes patients with higher differentiation, prior chemoradiotherapy, or other active cancers, and requires good performance status (ECOG 0–1). Enrollment centers on the Second Affiliated Hospital of Zhejiang University School of Medicine in Hangzhou, China, with a focus on standardized radiotherapy delivery and close follow-up to assess outcomes. The trial is designed as multicenter in design but currently lists a single participating institution, reflecting its early scope.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Dongjun Dai, Doctor
• Email: daidongjunmed@zju.edu.cn
• Phone: 86-0571-86992821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.