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

• Postoperative radiotherapy (Radiation): Radiation therapy should commence immediately after the surgical wound has fully healed, typically 4 to 6 weeks post-operation, but no later than 8 weeks post-operation

Primary outcomes

• 3-year DFS [3 years]: The survival time of patients without significant tumor growth from the date of randomization. The appearance of new lesions is used as the criterion for recurrence (including recurrence of the primary lesion and surrounding tissues, cervical lymph node metastasis, and distant metastasis), and the time point of recurrence is the date of the first observation of measurable new lesions. The disease-free survival period will be defined as the time from randomization to death for patients who die from any other cause before disease recurrence is recorded. Patients who have not experienced disease recurrence or death (i.e. disease-free survival) during analysis will have the time of the last efficacy evaluation as the endpoint. For disease-free survival patients who have not undergone tumor evaluation since the baseline period, the first day of treatment will be used as the endpoint of disease-free survival. Calculate the 3-year disease-free survival rate of all patients after follow-up.

Secondary outcomes

• 5-year OS [5 years]: From the date of randomization to the time of death caused by any reason. When recording lost patients until death, up to the last recorded time of contact with the patient. For patients who are still alive at the final analysis time point, their last contact time will be used as the survival time. During the analysis of survival and subsequent treatment, all patients were followed up until death, loss to follow-up, or termination of the study. The log rank test will be used to analyze the 5-year overall survival of all participants.
• 5-year DFS [5 years]: The definition is the same as above. Calculate the 5-year disease-free survival rate of all patients after follow-up.
• acute toxicity events [6 months]: Evaluate toxicity events within 6 months after radiotherapy according to the RTOG acute radiation injury grading criteria and CTCAE v5.0 criteria.
• Long-term toxicity events [from 6 months after treatment to 5 years after treatment]: according to CTCAE 5.0
• scores of Quality of life [From enrollment to 5 years]: according to The University of Washington Quality of Life 4.0

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 70 years old, gender not limited;
2. Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
3. Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
4. The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
5. Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
6. According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
7. Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
8. The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
9. 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:

1. Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
2. Have received chemotherapy or other anti-tumor drugs;
3. Previously received radiation therapy for the head and neck area;
4. Patients with active autoimmune diseases that require systemic treatment in the past;
5. Pregnant or lactating women;
6. Individuals with acute infections that are difficult to control;
7. Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
8. 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);
9. Researchers believe that there are other conditions that hinder patients from participating in this trial.