Radiotherapy after surgery for early-stage tongue cancer with high-risk features

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 is a prospective, multicenter, randomized, open-label trial comparing postoperative radiotherapy given 6–8 weeks after complete tumor resection versus simple follow-up in patients with early-stage (T1-2N0M0) oral tongue squamous cell carcinoma who have at least one high-risk pathological feature. Primary outcomes include 3- and 5-year disease-free survival; secondary outcomes include overall survival, treatment-related toxicity, and quality of life. Eligible patients are adults 18–70 with fully resected tumors limited to the anterior two-thirds of the tongue and pathological features such as vascular tumor thrombus, nerve invasion, or moderate/poor differentiation. Participants are randomized to receive adjuvant radiotherapy or observation and are followed at participating tertiary centers across China for outcome and safety monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first affiliated hospital, college of medicinle, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Not yet recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Chaoyang, Beijing Municipality, China Not yet recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Cancer prevention and treatment center, sun yat-sen university
  Guandong, Guangdong, China Not yet recruiting

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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.