Oral Tongue Squamous Cell CarcinomaPORT-ESTERNCT07402525
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
A study testing Postoperative radiotherapy in people with Oral Tongue Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 28 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Tongue Squamous Cell Carcinoma
- What is being tested?
- Postoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 28 sitesChina
- Study dates
- 26 Jan 2026to 30 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites, 28 recruiting
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233030
Hao Jiang, 0552-3086120, jianghao1223@163.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130033
Xin Jiang, 0431-88782222, jiangx@jlu.edu.cn
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Huaxin Duan, 0731-83929900, 317102912@qq.com
- Not yet recruiting
Hunan cancer hospital
Changsha, Hunan, 410008
Yaqian Han, MD/PhD, +86-18673176667, hanyaqian@hnca.org.cn
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, 410008
Haijun Wu, 0731-4328888, wuhaijun@csu.edu.cn
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, 100020
Ye Zhang, +86-13717635880, drzye1983@163.com
- Not yet recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
Shun Lu, 028-85420243, lushousi90036@163.com
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiupeng Lv, 0411-83635963, lvxiupeng1126@163.com
- Not yet recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Haichen Zhang, 0411-84671291, Zhanghaichen@dmu.edu.cn
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sufang Qiu, 0591-83660063, qiusufangf@163.com
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005
Jinsheng Hong, 0591-88712222, hjs703@126.com
- Not yet recruiting
Cancer prevention and treatment center, sun yat-sen university
Guandong, Guangdong, 510060
Fei Han, 020-87343535, ctc@sysucc.org.cn
- Recruiting
The first affiliated hospital, college of medicinle, Zhejiang University
Hangzhou, Zhejiang, 310009
Senxiang Yan, +86-13957162839, yansenxiang@zju.edu.cn
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310009
Feng Jiang, MD/PhD, +86-13858065192, Jiangfeng@zjcc.org.cn
- Recruiting
the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang
Qichun Wei, MD/PhD, +86 571 87783521, qichun_wei@zju.edu.cn
Qiaoying Tian, MD/PhD, +86-19858131366, 3150102475@zju.edu.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Chuncheng Hao, 0451-86298666, haochuncheng1980@163.com
- Not yet recruiting
Huzhou Center Hospital
Huzhou, Zhejiang, 313000
Lixin Ru, 0572-2023301, zsj6606@126.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Xiaochang Gong, 0791-833322, lijingao@hotmail.com
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315040
Zhenfei Xiang, 0574-55835583, rudolf13@163.com
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Haijun Lu, 0532-82911847, lhj82920608@163.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Chaosu Hu, 021-64175590, hucsu62@163.com
- Not yet recruiting
The Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Yang Wang, 021-54601999, janetcyj@163.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Qiao Qiao, 024-961200, braveheart8063@outlook.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Peiguo Wang, 022-23340123, yihaidaohang@163.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Changlin Zou, 0577-55578037, zcl19670115@163.com
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Guangyuan Hu, 027-83662688, h.g.y.121@163.com
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Xiangpan Li, 027-88041911, xtp470484112@126.com
- Not yet recruiting
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Rui Liu, 029-85323112, reon10@sina.com
About this study
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.
- Conditions
- Oral Tongue Squamous Cell Carcinoma
- Being tested
- Postoperative radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Postoperative radiotherapy |
| control group | No intervention | Patients will not receive special treatment and will undergo routine follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
5-year OS
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.
Measured: 5 years
5-year DFS
The definition is the same as above. Calculate the 5-year disease-free survival rate of all patients after follow-up.
Measured: 5 years
acute toxicity events
Evaluate toxicity events within 6 months after radiotherapy according to the RTOG acute radiation injury grading criteria and CTCAE v5.0 criteria.
Measured: 6 months
Long-term toxicity events
according to CTCAE 5.0
Measured: from 6 months after treatment to 5 years after treatment
scores of Quality of life
according to The University of Washington Quality of Life 4.0
Measured: From enrollment to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start26 Jan 2026
- Primary completion30 Jan 2031 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Tongue Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Province Tumor Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-Sen University Cancer Center, Shanghai Cancer Hospital, China, Tianjin Medical University Cancer Institute and Hospital, Xiangya Hospital of Central South University, Sichuan Cancer Hospital and Research Institute, Hunan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Hospital of Jilin University, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, First Affiliated Hospital of Fujian Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Huzhou Center Hospital, The Second Affiliated Hospital of Dalian Medical University, Huashan Hospital, First Affiliated Hospital of Zhejiang University, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Harbin Medical University, Fudan University
- Responsible party
- Principal investigator, Qichun Wei, MD, PhD, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402525
- Sponsor's protocol ID
- 2025-0846
- Acronym
- PORT-ESTER
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
- ClinicalTrials.gov ID
- NCT07402525
- Acronym / sponsor ID
- PORT-ESTER / 2025-0846
- Conditions
- Oral Tongue Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hunan Province Tumor Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-Sen University Cancer Center, Shanghai Cancer Hospital, China, Tianjin Medical University Cancer Institute and Hospital, Xiangya Hospital of Central South University, Sichuan Cancer Hospital and Research Institute, Hunan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Hospital of Jilin University, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, First Affiliated Hospital of Fujian Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Huzhou Center Hospital, The Second Affiliated Hospital of Dalian Medical University, Huashan Hospital, First Affiliated Hospital of Zhejiang University, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Harbin Medical University, Fudan University
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 30 Jan 2031 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PORT group | Experimental | Radiation: Postoperative radiotherapyPatients 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 |
| control group | No intervention | –Patients will not receive special treatment and will undergo routine follow-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative radiotherapyRadiation 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 | Radiation | PORT group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
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Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma
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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
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A Dye for the Detection of Cancer of the Tongue and Mouth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative radiotherapy in people with Oral Tongue Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.