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Recruiting NCT07402525

Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial

No phase Interventional Oral Tongue Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Postoperative radiotherapy.
Who it may be relevant to
Registry conditions: Oral Tongue Squamous Cell Carcinoma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Radiation Postoperative radiotherapy
    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

Primary outcome measures

  • 3-year DFS [Time frame: 3 years]
Secondary outcome measures (5)
  • 5-year OS [Time frame: 5 years]
  • 5-year DFS [Time frame: 5 years]
  • acute toxicity events [Time frame: 6 months]
  • Long-term toxicity events [Time frame: from 6 months after treatment to 5 years after treatment]
  • scores of Quality of life [Time frame: From enrollment to 5 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old and ≤ 70 years old, gender not limited;
  • Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
  • Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
  • The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
  • Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
  • According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
  • Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
  • The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
  • 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

  • Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
  • Have received chemotherapy or other anti-tumor drugs;
  • Previously received radiation therapy for the head and neck area;
  • Patients with active autoimmune diseases that require systemic treatment in the past;
  • Pregnant or lactating women;
  • Individuals with acute infections that are difficult to control;
  • Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
  • 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);
  • Researchers believe that there are other conditions that hinder patients from participating in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 28 centers
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Cancer Hospital Chinese Academy of Medical Sciences — Chaoyang
  • Fujian Cancer Hospital — Fuzhou
  • Cancer prevention and treatment center, sun yat-sen university — Guandong
  • Harbin Medical University Cancer Hospital — Harbin
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • Renmin Hospital of Wuhan University — Wuhan
  • Hunan Provincial People's Hospital — Changsha
  • … and 20 more centers

Identifiers

NCT: NCT07402525 · 2025-0846

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗