Oral CancerNCT06623266
Neck Observation or Elective Neck Dissection in cT1N0M0 OSCC
A study testing Neck management in people with Oral Cancer and Lymph Node Metastasis, run by Huashan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Cancer, Lymph Node Metastasis
- What is being tested?
- Neck management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2024to 30 Sep 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara
- Clinical stage is cT1N0M0 (AJCC 8th edition)
- Pathological diagnosis of squamous cell carcinoma
- Sign the informed consent form
Who cannot join
- More than 2 lesions found in the oral cavity
- Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)
- History of unilateral or bilateral neck dissection in the past
- History of previous head and neck radiotherapy
- Pregnant or lactating women
- Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation
- Participated in other clinical studies within 30 days before enrollment
- Other circumstances that the researcher considers unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Lai-ping Zhong, MD, PhD, +862152888915, zhonglp@hotmail.com
Liang Gu, MD, +862152889999 ext. 7182, kqyxyhyy@163.com
About this study
Official title: Neck Observation Versus Selective Neck Dissection in Patients With cT1N0M0 Oral Squamous Cell Carcinoma: A Multicenter Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Oral Cancer, Lymph Node Metastasis
- Being tested
- Neck management
- Keywords
- Oral squamous cell carcinoma, Early stage, Neck dissection, Neck observation, Lymph node metastasis rate
- Medical subject headings
- Mouth Neoplasms, Lymphatic Metastasis, 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.
Neck managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Placebo comparator | 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. Receives: Procedure: Neck management |
| Control arm | Active comparator | 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. Receives: Procedure: Neck management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start26 Sep 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- 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
- Model description
- Randomized 1:1 to the experimental or 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-ping Zhong, Huashan Hospital
- Investigators
- Lai-ping Zhong, MD, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623266
- Sponsor's protocol ID
- Acromion
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Observation Versus Selective Neck Dissection in Patients With cT1N0M0 Oral Squamous Cell Carcinoma: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06623266
- Acronym / sponsor ID
- Acromion
- Conditions
- Oral Cancer, Lymph Node Metastasis
- Keywords
- Oral squamous cell carcinoma, Early stage, Neck dissection, Neck observation, Lymph node metastasis rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 2 Oct 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 to the experimental or 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Placebo comparator | Procedure: Neck managementThe 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. |
| Control arm | Active comparator | Procedure: Neck managementThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara
- Clinical stage is cT1N0M0 (AJCC 8th edition)
- Pathological diagnosis of squamous cell carcinoma
- Sign the informed consent form
Key exclusion criteria (8 listed)
- More than 2 lesions found in the oral cavity
- Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)
- History of unilateral or bilateral neck dissection in the past
- History of previous head and neck radiotherapy
- 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 |
|---|---|---|
| Neck managementIn 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. | Procedure or surgery | Control arm, Experimental arm |
Primary outcome
Rate of 2-year lymph node metastasis
Time frame: 2 years
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.
3 secondary outcomes
Rate of 2-year disease free survival
Time frame: 2 years
Rate of 2-year overall survival
Time frame: 2 years
Health-related quality of life
Time frame: 2 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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. After the completion of the trial.
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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.
Lai-ping Zhong, MD, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck management in people with Oral Cancer and Lymph Node Metastasis, run by Huashan Hospital at 1 site 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 4 inclusion and 8 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Contact Lai-ping Zhong, MD, PhD (+862152888915, zhonglp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 2-year lymph node metastasis (time frame: 2 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 21 Sep 2026.