Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial

Inclusion criteria

• Age ≥ 18 years old and ≤ 70 years old, gender not limited;
• Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
• Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
• The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
• Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
• According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
• Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
• The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
• Not participating in other clinical trials within the previous 4 weeks prior to screening; If other trials fail to screen cases, but meet the requirements of this trial, they can be enrolled.

Exclusion criteria

• Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
• Have received chemotherapy or other anti-tumor drugs;
• Previously received radiation therapy for the head and neck area;
• Patients with active autoimmune diseases that require systemic treatment in the past;
• Pregnant or lactating women;
• Individuals with acute infections that are difficult to control;
• Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
• The subjects also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years);
• Researchers believe that there are other conditions that hinder patients from participating in this trial.