Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure

Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure: 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. Glottic carcinoma with anterior commissure invasion is linked to inferior local control; both definitive radiotherapy alone or transoral laser microsurgery (TLM) may confer a higher risk of local recurrence compared with other glottic carcinomas. We hypothesize that postoperative radiotherapy can act as an effective adjunct to surgery and reduce recurrence rates in patients with glottic carcinoma involving the anterior commissure. This study aims to conduct a multicenter, prospective, single arm phase II clinical trial of intensity modulated radiotherapy (IMRT) for postoperative patients with early stage glottic laryngeal carcinoma and anterior commissure involvement, to preliminarily evaluate the effect of IMRT on local control rates and long term survival outcomes in this patient population.

Inclusion Criteria:

1. Aged 18 years or older, regardless of gender;
2. Pathologically confirmed glottic squamous cell carcinoma;
3. T1-T2N0M0 glottic laryngeal carcinoma with anterior commissure involvement;
4. Patients who have undergone curative intent surgery for glottic carcinoma with negative surgical margins, within 4-8 weeks post operation;
5. No prior radiotherapy, chemotherapy or other anti neoplastic agent treatment;
6. ECOG performance status of 0 or 1;
7. Signed informed consent form.

Exclusion Criteria:

1. Patients without anterior commissure involvement;
2. Prior chemotherapy or treatment with other anti neoplastic agents;
3. Prior history of head and neck radiotherapy;
4. Prior participation in other clinical trials;
5. Patients with severe allergy history or allergic diathesis, e.g., contrast medium allergy;
6. Pregnant or lactating women;
7. Patients with uncontrolled acute infection;
8. Patients with drug addiction, substance abuse, chronic heavy alcohol consumption, or human immunodeficiency virus (HIV) infection;
9. Patients with other uncontrolled concurrent malignancies.