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

February 4, 2026 updated by: Qichun Wei, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China, 410008
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Fuzhou, China, 350005
        • Not yet recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Anhui
      • Bengbu, Anhui, China, 233030
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
    • Beijing Municipality
      • Chaoyang, Beijing Municipality, China, 100020
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Guandong, Guangdong, China, 510060
        • Not yet recruiting
        • Cancer prevention and treatment center, sun yat-sen university
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130033
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Not yet recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Dalian, Liaoning, China, 116027
        • Not yet recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • The Affiliated Hospital Of Qingdao University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200040
        • Not yet recruiting
        • The Huashan Hospital Affiliated to Fudan University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital & Institute
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
        • Contact:
        • Contact:
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The first affiliated hospital, college of medicinle, Zhejiang University
        • Contact:
      • Huzhou, Zhejiang, China, 313000
        • Not yet recruiting
        • Huzhou Center Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315040
        • Not yet recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PORT group
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
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
No Intervention: control group
Patients will not receive special treatment and will undergo routine follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year DFS
Time Frame: 3 years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year OS
Time Frame: 5 years
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.
5 years
5-year DFS
Time Frame: 5 years
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
Time Frame: 6 months
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
Time Frame: from 6 months after treatment to 5 years after treatment
according to CTCAE 5.0
from 6 months after treatment to 5 years after treatment
scores of Quality of life
Time Frame: From enrollment to 5 years
according to The University of Washington Quality of Life 4.0
From enrollment to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Zhejiang Cancer Hospital
Xiangya Hospital of Central South University
Fudan University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fujian Cancer Hospital
Huashan Hospital
First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Qingdao University
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Zhejiang University
Tianjin Medical University Cancer Institute and Hospital
Jiangxi Provincial Cancer Hospital
The First Hospital of Jilin University
Hunan Provincial People's Hospital
Renmin Hospital of Wuhan University
Shanghai Cancer Hospital, China
First Hospital of China Medical University
Hunan Province Tumor Hospital
First Affiliated Hospital of Wenzhou Medical University
The Second Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital of Dalian Medical University
Sichuan Cancer Hospital and Research Institute
The Second Affiliated Hospital of Dalian Medical University
Sun Yat-sen University Cancer Hosptial
The First Affiliated Hospital of Bengbu Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Huzhou Center Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

January 30, 2031

Study Completion (Estimated)

July 30, 2031

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Tongue Squamous Cell Carcinoma

Clinical Trials on Postoperative radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe