RecruitingNot ApplicableNCT07402525

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

Enrollment

190 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether adding radiation therapy after surgery improves outcomes for people with early-stage tongue cancer who have certain features that suggest a higher chance of the cancer coming back (called "risk factors"). **You may be eligible if...** - You are 18–70 years old - You have newly diagnosed squamous cell carcinoma of the front two-thirds of the tongue (early stage T1-2N0M0) - The tumor was completely removed during surgery with no remaining cancer - You have at least one risk factor: cancer cells in blood vessels, nerve invasion, or poorly differentiated tumor cells - You have not had prior radiation, chemotherapy, or targeted therapy **You may NOT be eligible if...** - Your cancer is at an advanced stage or has spread to lymph nodes or other organs - You have already received prior cancer treatments - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPostoperative 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

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NCT07402525


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