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

The goal of this clinical trial is to learn whether postoperative radiotherapy can delay disease recurrence in patients with early-stage oral squamous cell carcinoma who have high-risk factors. The main question it aims to answer is: Is the clinical outcome of early-stage tongue squamous cell carcinoma patients with risk factors after tumor enlargement resection receiving postoperative radiotherapy better than that of patients with simple follow-up observation? How is the safety? Researchers will compare the postoperative radiotherapy group and the simple follow-up observation group to see if there are differences between the two groups in terms of 3-year disease-free survival rate, 5-year disease-free survival rate, overall survival rate, toxicity events, and quality of life. Participants of postoperative radiotherapy group will receive postoperative radiotherapy 6-8 weeks after surgery.

NCT Number	NCT07402525
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: Hunan Province Tumor Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-Sen University Cancer Center, Shanghai Cancer Hospital, China, Tianjin Medical University Cancer Institute and Hospital, Xiangya Hospital of Central South University, Sichuan Cancer Hospital and Research Institute, Hunan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Hospital of Jilin University, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, First Affiliated Hospital of Fujian Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Huzhou Center Hospital, The Second Affiliated Hospital of Dalian Medical University, Huashan Hospital, First Affiliated Hospital of Zhejiang University, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Harbin Medical University, Fudan University
Conditions	Oral Tongue Squamous Cell Carcinoma
Enrollment	190 participants
Start Date	2026-01-26
Primary Completion	2031-01-30 (estimated)
Study Completion	2031-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-11