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.

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