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Postoperative radiotherapy for early-stage oral tongue squamous cell carcinoma patients with risk factors: a prospective, multicenter, randomized controlled, open-labelled, phase III trial

Postoperative radiotherapy for early-stage oral tongue squamous cell carcinoma patients with risk factors: a prospective, multicenter, randomized controlled, open-labelled, phase III trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111397
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral tongue squamous cell carcinoma

Interventions

follow-up group:-
PORT group:postoperative radiotherapy

Sponsors

The second affiliated hospital of Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 and <= 70 years, gender not restricted; 2.Previously untreated patients (no prior radiotherapy, chemotherapy or targeted therapy); 3.Complete resection of the tumor by the naked eye and no residual tumor found in postoperative pathology; 4.Lesions limited to the anterior 2/3 of the tongue (mobile part of the tongue); 5.Postoperative pathology confirmed as tongue squamous cell carcinoma; 6.According to the 8th edition of AJCC, the pathological TNM stage is T1-2N0M0; 7.At least one risk factor: lymphovascular invasion, perineural infiltration, moderately differentiated or poorly differentiated; 8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 9.No participation in other clinical trials within 4 weeks before screening; if cases failed screening in other trials but meet the requirements of this trial, they can be included;

Exclusion criteria

Exclusion criteria: 1.Patients with invasion of the oropharynx, floor of the mouth, cheek, neck or other organs; 2.Received chemotherapy or other anti-tumor drugs; 3.Previously received radiotherapy to the head and neck; 4.Patients with active autoimmune diseases requiring systemic treatment; 5.Pregnant or lactating women; 6.Patients with acute infections that are difficult to control; 7.Drug addicts, drug abusers, long-term alcoholics and AIDS patients; 8.Patients with other known invasive malignant tumors (except those with no evidence of tumor recurrence after treatment and a duration of more than 2 years); 9.Other conditions that the investigator deems to hinder the patient's participation in this trial;

Design outcomes

Primary

MeasureTime frame
3-years DFS;

Secondary

MeasureTime frame
5-years OS;5-years DFS;toxic events;Quality of Life;

Countries

China

Contacts

Public ContactQichun Wei

The second affiliated hospital of Zhejiang University school of medicine

qichun_wei@zju.edu.cn+86 571 8778 3521

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026