Actively Recruiting
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-02-11
190
Participants Needed
28
Research Sites
287 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
H
Hunan Province Tumor Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, any gender
- Newly treated patients who have not had radiotherapy, chemotherapy, or targeted therapy before
- Complete tumor removal with no residual tumor in postoperative pathology
- Tumor limited to the front two-thirds of the tongue
- Postoperative diagnosis of squamous cell carcinoma of the tongue
- Pathological stage T1-2N0M0 according to AJCC 8th edition
- At least one risk factor: vascular cancer thrombus, nerve invasion, or moderate/low differentiation
- Eastern Cancer Collaboration Group (ECOG) performance status score of 0 to 2
- Not enrolled in other clinical trials within 4 weeks before screening; exceptions apply if other trials failed to enroll cases
You will not qualify if you...
- Cancer invasion into oropharynx, mouth floor, cheeks, neck, or other organs
- Previous chemotherapy or anti-tumor drug treatment
- Prior radiation therapy to head and neck area
- Active autoimmune diseases requiring systemic treatment in the past
- Pregnant or breastfeeding women
- Acute infections that are difficult to control
- History of drug abuse, long-term alcoholism, or AIDS
- Presence of other invasive malignant tumors unless treated with no recurrence for over 2 years
- Any other conditions that researchers believe would prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233030
Not Yet Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, China, 100020
Not Yet Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
4
Cancer prevention and treatment center, sun yat-sen university
Guandong, Guangdong, China, 510060
Not Yet Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
6
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
7
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Not Yet Recruiting
8
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Not Yet Recruiting
9
Hunan cancer hospital
Changsha, Hunan, China, 410008
Not Yet Recruiting
10
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
11
The First Hospital of Jilin University
Changchun, Jilin, China, 130033
Not Yet Recruiting
12
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
Not Yet Recruiting
13
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116027
Not Yet Recruiting
14
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Not Yet Recruiting
15
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
16
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Not Yet Recruiting
17
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
18
The Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Not Yet Recruiting
19
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
20
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
21
The first affiliated hospital, college of medicinle, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
22
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
23
the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang, China
Actively Recruiting
24
Huzhou Center Hospital
Huzhou, Zhejiang, China, 313000
Not Yet Recruiting
25
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315040
Not Yet Recruiting
26
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
27
Xiangya Hospital of Central South University
Changsha, China, 410008
Not Yet Recruiting
28
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China, 350005
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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