Oral Squamous Cell CarcinomaNCT05806073
Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma
A study testing Elective neck dissection and Therapeutic neck dissection in people with Oral Squamous Cell Carcinoma and Neck Dissection, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Neck Dissection
- What is being tested?
- Elective neck dissection and Therapeutic neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2026
- 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
- Histologically proven T1 or T2 N1 M0( AJCC 8th) squamous call carcinoma of tongue(except base of the tongue ), buccal mucosa, upper and lower gums, hard palate and floor of mouth;
- No history of chemotherapy, radiotherapy or targeted therapy,for any reason before
- No history of a prior malignancy in head and neck region
- No history of a prior malignancy outside head and neck region in the preceding 5 years
- Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1;
- Participants will be reliable for follow-up
- Understanding the protocol and is able to give informed consent
Who cannot join
- failed to obtain the signed written informed consent;
- definite distant metastasis or other malignant tumor;
- Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy);
- previously received radiotherapy for primary tumors or lymph nodes;
- previously received anti-tumor biological targeted therapy;
- Chemotherapy or immunotherapy has been applied to the primary tumor in the past;
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- Patients with any malignant tumor in the past 5 years (except the cured basal cell carcinoma of the skin or cervical carcinoma in situ)；
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction that occurred in the first 12 months, serious arrhythmia requiring medical treatment, liver, kidney or metabolic diseases);
- known human immunodeficiency virus (HIV) infection;
- chronic diseases requiring immune preparations or hormone treatment;
- pregnant or lactating women;
- drug/alcohol abuse, or suffering from psychological or mental diseases that may interfere with research compliance;
- Epilepsy patients who need medical treatment (such as steroids or antiepileptic drugs);
- participated in other clinical trials in the past 30 days;
- cases that the researcher thinks are not suitable for joining the group.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V".
Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.
Read the detailed description
There are controversies on the benefits of therapeutic neck dissection (I-V region) for clinically T1-2N1M0 oral squamous cell carcinoma(cT1-2N1M0). The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the safety of elective neck dissection (I-III region) for patients of cT1-2N1M0. We initiate this study, expecting 188 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: "elective neck dissection (END)" and "therapeutic neck dissection (TND)". The END group will undergo one stage surgery of END and primary tumor excision, and the TND group will be treated with one stage surgery of TND and primary tumor excision. All patients will be followed up with at least 2 years after initial treatment, and the neck recurrence rate (primary outcome measures), postoperative complication rate, quality of life and survival between groups will be compared.
- Conditions
- Oral Squamous Cell Carcinoma, Neck Dissection
- Being tested
- Elective neck dissection, Therapeutic neck dissection
- 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.
Elective neck dissectionProcedure or surgery
patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor
Therapeutic neck dissectionProcedure or surgery
patient underwent Therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor
| Study group | Role | What they receive |
|---|---|---|
| Elective neck dissection | Experimental | patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor Receives: Procedure: Elective neck dissection |
| Therapeutic neck dissection | Experimental | Patient underwent therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor Receives: Procedure: Therapeutic neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of neck
From date of randomization until the date of metastasis of ipsilateral or contralateral cervical lymph nodes
Measured: up to 2 year
Secondary outcomes (1)
Overall survival
From date of randomization until the date of death from any cause
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806073
- Sponsor's protocol ID
- SH9H-2022-T349-2
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 12 Apr 2023
- Results posted
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05806073
- Acronym / sponsor ID
- SH9H-2022-T349-2
- Conditions
- Oral Squamous Cell Carcinoma, Neck Dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2023 (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.
Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V".
Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.
Detailed description
There are controversies on the benefits of therapeutic neck dissection (I-V region) for clinically T1-2N1M0 oral squamous cell carcinoma(cT1-2N1M0). The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the safety of elective neck dissection (I-III region) for patients of cT1-2N1M0. We initiate this study, expecting 188 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: "elective neck dissection (END)" and "therapeutic neck dissection (TND)". The END group will undergo one stage surgery of END and primary tumor excision, and the TND group will be treated with one stage surgery of TND and primary tumor excision. All patients will be followed up with at least 2 years after initial treatment, and the neck recurrence rate (primary outcome measures), postoperative complication rate, quality of life and survival between groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective neck dissection | Experimental | Procedure: Elective neck dissectionpatient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor |
| Therapeutic neck dissection | Experimental | Procedure: Therapeutic neck dissectionPatient underwent therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven T1 or T2 N1 M0( AJCC 8th) squamous call carcinoma of tongue(except base of the tongue ), buccal mucosa, upper and lower gums, hard palate and floor of mouth;
- No history of chemotherapy, radiotherapy or targeted therapy,for any reason before
- No history of a prior malignancy in head and neck region
- No history of a prior malignancy outside head and neck region in the preceding 5 years
- Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1;
Key exclusion criteria (15 listed)
- failed to obtain the signed written informed consent;
- definite distant metastasis or other malignant tumor;
- Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy);
- previously received radiotherapy for primary tumors or lymph nodes;
- previously received anti-tumor biological targeted therapy;
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 |
|---|---|---|
| Elective neck dissectionpatient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor | Procedure or surgery | Elective neck dissection |
| Therapeutic neck dissectionpatient underwent Therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor | Procedure or surgery | Therapeutic neck dissection |
Primary outcome
Recurrence rate of neck
Time frame: up to 2 year
From date of randomization until the date of metastasis of ipsilateral or contralateral cervical lymph nodes
1 secondary outcome
Overall survival
Time frame: up to 2 year
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 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Elective neck dissection and Therapeutic neck dissection in people with Oral Squamous Cell Carcinoma and Neck Dissection, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Hong Zhen (+86-（021）23271699 ext. 5576, hannannan111@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of neck (time frame: up to 2 year). 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 12 Apr 2023.