An interventional study of Postoperative radiotherapy in Oral Tongue Squamous Cell Carcinoma, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 28 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 190 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
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
Radiation: Postoperative radiotherapy
Patients will not receive special treatment and will undergo routine follow-up.
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
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.
Time frame: 3 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Long-term toxicity events
according to CTCAE 5.0
Time frame: 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
Time frame: From enrollment to 5 years
Plan to share: Undecided
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Second Affiliated Hospital, School of Medicine, Zhejiang University