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| Name | Class |
|---|---|
| Hunan Province Tumor Hospital | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Sun Yat-Sen University Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PORT group | Experimental | Patients should start radiotherapy immediately after the surgical wound has fully healed, usually 4 to 6 weeks after surgery, with a requirement of no later than 8 weeks after surgery |
|
| control group | No Intervention | Patients will not receive special treatment and will undergo routine follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative radiotherapy | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year DFS | The survival time of patients without significant tumor growth from the date of randomization. The appearance of new lesions is used as the criterion for recurrence (including recurrence of the primary lesion and surrounding tissues, cervical lymph node metastasis, and distant metastasis), and the time point of recurrence is the date of the first observation of measurable new lesions. The disease-free survival period will be defined as the time from randomization to death for patients who die from any other cause before disease recurrence is recorded. Patients who have not experienced disease recurrence or death (i.e. disease-free survival) during analysis will have the time of the last efficacy evaluation as the endpoint. For disease-free survival patients who have not undergone tumor evaluation since the baseline period, the first day of treatment will be used as the endpoint of disease-free survival. Calculate the 3-year disease-free survival rate of all patients after follow-up. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year OS | From the date of randomization to the time of death caused by any reason. When recording lost patients until death, up to the last recorded time of contact with the patient. For patients who are still alive at the final analysis time point, their last contact time will be used as the survival time. During the analysis of survival and subsequent treatment, all patients were followed up until death, loss to follow-up, or termination of the study. The log rank test will be used to analyze the 5-year overall survival of all participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Not yet recruiting | Bengbu | Anhui | 233030 | China |
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| Shanghai Cancer Hospital, China |
| OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The First Hospital of Jilin University | OTHER |
| First Hospital of China Medical University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Zhejiang Cancer Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Huzhou Center Hospital | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Huashan Hospital | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Fudan University | OTHER |
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| 5 years |
| 5-year DFS | The definition is the same as above. Calculate the 5-year disease-free survival rate of all patients after follow-up. | 5 years |
| acute toxicity events | Evaluate toxicity events within 6 months after radiotherapy according to the RTOG acute radiation injury grading criteria and CTCAE v5.0 criteria. | 6 months |
| Long-term toxicity events | according to CTCAE 5.0 | from 6 months after treatment to 5 years after treatment |
| scores of Quality of life | according to The University of Washington Quality of Life 4.0 | From enrollment to 5 years |
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Chaoyang | Beijing Municipality | 100020 | China |
|
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
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| Cancer prevention and treatment center, sun yat-sen university | Not yet recruiting | Guandong | Guangdong | 510060 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430060 | China |
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| Hunan Provincial People's Hospital | Not yet recruiting | Changsha | Hunan | 410005 | China |
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| Hunan cancer hospital | Not yet recruiting | Changsha | Hunan | 410008 | China |
|
| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | 330029 | China |
|
| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130033 | China |
|
| The First Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116011 | China |
|
| The Second Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116027 | China |
|
| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
|
| the First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
|
| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266000 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| The Huashan Hospital Affiliated to Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Sichuan Cancer Hospital & Institute | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| The first affiliated hospital, college of medicinle, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009 | Recruiting | Hangzhou | Zhejiang | China |
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| Huzhou Center Hospital | Not yet recruiting | Huzhou | Zhejiang | 313000 | China |
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| Ningbo Medical Center Lihuili Hospital | Not yet recruiting | Ningbo | Zhejiang | 315040 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | 410008 | China |
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| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | 350005 | China |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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