NCT07402525

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
63mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Jul 2031

Study Start

First participant enrolled

January 26, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2031

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2031

Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Oral Tongue Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (5)

  • 5-year OS

    5 years

  • 5-year DFS

    5 years

  • acute toxicity events

    6 months

  • Long-term toxicity events

    from 6 months after treatment to 5 years after treatment

  • scores of Quality of life

    From enrollment to 5 years

Study Arms (2)

PORT group

EXPERIMENTAL

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

control group

NO INTERVENTION

Patients will not receive special treatment and will undergo routine follow-up.

Interventions

Postoperative radiotherapyRADIATION

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

PORT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233030, China

NOT YET RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Chaoyang, Beijing Municipality, 100020, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Cancer prevention and treatment center, sun yat-sen university

Guandong, Guangdong, 510060, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

NOT YET RECRUITING

Hunan cancer hospital

Changsha, Hunan, 410008, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130033, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

NOT YET RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

The Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

The first affiliated hospital, college of medicinle, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009

Hangzhou, Zhejiang, China

RECRUITING

Huzhou Center Hospital

Huzhou, Zhejiang, 313000, China

NOT YET RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315040, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, 410008, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005, China

NOT YET RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

January 26, 2026

Primary Completion (Estimated)

January 30, 2031

Study Completion (Estimated)

July 30, 2031

Last Updated

February 11, 2026

Record last verified: 2026-01

Locations

CN(28)