An interventional study of Neck management in Oral Cancer and Lymph Node Metastasis, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
Among 32 studies in Mouth Neoplasms with a site in China — 17 open to participants now, 19 under way, 2 of them phase 3. Mouth Neoplasms · China.
Among the 32 studies in Mouth Neoplasms with a site in China, this one has the largest planned enrollment of the 27 interventional ones, is the only one that started in 2024, is one of 8 with no phase, reaches primary completion later than 16 of the 18 other live ones, and was the 21st registered.
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →17 of the 32 studies in Mouth Neoplasms with a site in China are open now, in 2 countries. Each count lists the studies.
Of the 97 Mouth Neoplasms studies recruiting now, 58 (60%) set no upper age limit and 23 (24%) stop at 75 or younger; 5 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2024.
Median enrollment 72 across the 27 interventional studies, 206 across the 5 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
None of the 32 has an industry lead sponsor. The 10 most frequent:
Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
Huashan Hospital has 1 study filed under Mouth Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Mouth Neoplasms with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07714967Hainan Medical CollegeEffects of a Perma-h Model Mobile-based Rehabilitation Support Program on Hope, Self-efficacy, Perceived Social Support and Rehabilitation Outcomes in Post- Tracheostomy Oral Cancer Patients | 2026-11-01 |
| NCT07466810Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityResection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology | 2027-04-01 |
| NCT06130332Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNeoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004) | 2027-08-31 |
Among the 32 studies in Mouth Neoplasms with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.
For the patients with cT1N0M0 oral squamous cell carcinoma (OSCC), surgical resection of primary lesion is the preferred treatment. However, there are still debates on the neck management, some surgeons suggest elective neck dissection (END), and some surgeons suggest neck observation (NOB). The advantage of elective neck dissection is to clear the potential occult neck lymph node metastasis (about 15%), which could not be detected by clinical examination and imaging examination, and the disadvantage of END is to cause neck deformity, large scars, stiff neck and shoulders, difficulty in raising shoulders, and increase medical costs. The disadvantage of NOB is the risk of lymph node metastasis and disease progression. However, recent retrospective studies show that END has no potential benefit in improving survival in cT1N0M0 patients. The aim of the present trial is to compare the clinical outcomes between the cT1N0M0 OSCC patients, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only, on the aspects of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life. A total number of 300 patients will be recruited, including 150 patients in the experimental arm and 150 patients in the control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Control arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection. A complete medical history will be obtained and tumor assessment will be performed at baseline. Patients will be followed-up by every three months in the first 2 years, every six months in the next 3-5 years, and once a year thereafter until death or data censoring. Two-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life will be collected and analyzed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients in the experimental arm will receive radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.
Procedure: Neck management
The patients in the control arm will receive radical resection of the primary lesion with the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion, they will also receive simultaneous elective neck dissection. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.
Procedure: Neck management
In the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions. In the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.
Rate of 2-year lymph node metastasis
Lymph node metastasis is confirmed by pathological examinations, using fine needle aspiration cytology or biopsy. The rate of 2-year lymph node metastasis rate is reported as the percentage of patients who are free from lymph node metastasis for 2 years from the date of randomization.
Time frame: 2 years
Rate of 2-year disease free survival
Disease free survival is calculated from the date of randomization to local recurrence, regional recurrence, distant metastasis or death. The rate of 2-year disease free survival is reported as the percentage of patients who are disease free survival for 2 years from the date of randomization.
Time frame: 2 years
Rate of 2-year overall survival
Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization.
Time frame: 2 years
Health-related quality of life
Health-related quality of life will be measured and scored using the Chinese version of the University of Washington Quality of Life (UW-QOL) scale. Each score ranges from 0 to 100 points. The lower the score, the worse the functional perception.
Time frame: 2 years
Plan to share: Yes — After the completion of the trial.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 2 years after completion of the trial, for 6 months.
Access criteria: Data can be obtained upon scientifically sound request from the study PI, who will contact the Clinical Research Unit, Huashan Hospital, Fudan University. Access will be released after the approval from the Clinical Research Unit.
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Sep 2028, 48 months after the start.
Of 98 non-industry interventional studies with no phase under Mouth Neoplasms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 97. This study's planned 48 months is above that.
Counting every sponsor, half of 99 studies reached it within 30 months; a quarter within 17 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
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