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

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

This trial tests whether giving radiotherapy after surgery helps people with early-stage tongue squamous cell carcinoma who have certain high-risk features stay cancer-free longer than simple follow-up.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 28 sites (Bengbu, Anhui and 27 other locations)
• Trial ID: NCT07402525 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–70 with completely resected T1-2N0M0 tongue squamous cell carcinoma who have at least one high-risk pathological feature (vascular tumor thrombus, nerve invasion, or moderate/low differentiation) and ECOG performance status 0–2 are ideal candidates.

Not a fit: Patients without those high-risk features, with residual tumor, prior radiotherapy/chemotherapy, or tumors extending beyond the anterior two-thirds of the tongue are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adjuvant radiotherapy could reduce the risk of cancer recurrence and improve long-term outcomes for higher-risk early-stage tongue cancer patients.

How similar studies have performed: Retrospective series and single-center reports suggest adjuvant radiotherapy can lower local recurrence for high-risk oral tongue cancers, but randomized multicenter evidence is limited, so the approach is plausible but not yet definitively proven.

Eligibility criteria

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 this trial is running

Bengbu, Anhui and 27 other locations

• 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)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Hunan cancer hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• the First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Sichuan Cancer Hospital & Institute — Chengdu, Sichuan, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The first affiliated hospital, college of medicinle, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009 — Hangzhou, Zhejiang, China (Recruiting)
• Huzhou Center Hospital — Huzhou, Zhejiang, China (Not_yet_recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, China (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (Not_yet_recruiting)

Conditions Oral Tongue Squamous Cell Carcinoma