NCT07402525 Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
| NCT ID | NCT07402525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Oral Tongue Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2031-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2026-01-26 with a primary completion date of 2031-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 70 years old, gender not limited; 2. Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before); 3. Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology; 4. The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue); 5. Postoperative pathological diagnosis was squamous cell carcinoma of the tongue; 6. According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0; 7. Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation; 8. The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points; 9. Not participating in other clinical trials within the previous 4 weeks prior to screening; If other trials fail to screen cases, but meet the requirements of this trial, they can be enrolled. Exclusion Criteria: 1. Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs; 2. Have received chemotherapy or other anti-tumor drugs; 3. Previously received radiation therapy for the head and neck area; 4. Patients with active autoimmune diseases that require systemic treatment in the past; 5. Pregnant or lactating women; 6. Individuals with acute infections that are difficult to control; 7. Patients with drug abuse, drug abuse, long-term alcoholism and AIDS; 8. The subjects also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years); 9. Researchers believe that there are other conditions that hinder patients from participating in this trial.
Frequently Asked Questions
Who can join the NCT07402525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Oral Tongue Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07402525 currently recruiting?
Yes, NCT07402525 is actively recruiting participants. Visit ClinicalTrials.gov or contact Second Affiliated Hospital, School of Medicine, Zhejiang University to inquire about joining.
Where is the NCT07402525 trial being conducted?
This trial is being conducted at Bengbu, China, Chaoyang, China, Fuzhou, China, Guandong, China and 11 additional locations.
Who is sponsoring the NCT07402525 clinical trial?
NCT07402525 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 190 participants.