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Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2026-01-26
Completion Date
2031-07-30
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Postoperative radiotherapy
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
Locations (28)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Cancer prevention and treatment center, sun yat-sen university
Guandong, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Hunan cancer hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The first affiliated hospital, college of medicinle, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang, China
Huzhou Center Hospital
Huzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Xiangya Hospital of Central South University
Changsha, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China