Mouth NeoplasmsSECOND N0NCT05774483
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
A study testing Sentinel Node Biopsy and Limited Elective Neck Dissection in people with Mouth Neoplasms and Oral Cancers, run by Tata Memorial Hospital at 3 sites in India.
Trial summary
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mouth Neoplasms, Oral Cancers, Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Sentinel Node Biopsy and Limited Elective Neck Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 3 sitesIndia
- Study dates
- 16 Apr 2025to Apr 2034
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years of age
- Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM 8 edition
- Clinicoradiologically node negative
- Amenable to per oral excision
- Treatment naïve
- No other site of malignancy
Who cannot join
- Previous surgery in the head and neck region,
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesions
- Previous malignancy in the head and neck region
- Patients requiring the free flap reconstruction
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Richa Vaish, MS, M.Ch, 022-24177000 ext. 7238, drvaishricha@gmail.com
- Not yet recruiting
ACTREC
Navi Mumbai, Maharashtra
Richa Vaish, MS, M.Ch, 022-24177000, drvaishricha@gmail.com
- Not yet recruiting
Mpmmcc & Hbch
Varanasi, Uttar Pradesh
Aseem Mishra, MS, M.Ch, 0542-6917700, draseemmishra@gmail.com
About this study
Official title: Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers.
The main questions it aims to answer are:
- Survival outcomes
- Morbidity outcomes
- Cost-effectiveness
Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.
Read the detailed description
Based on the current literature, we know that elective neck dissection (END) is mandatory in clinically node-negative early oral cancers. However, this leads to overtreatment and morbidity in about 55-80% of patients. The emergence of recent level I evidence makes SNB the standard of care in this setting. However, its limitation of being a two-staged procedure, steep learning curve, the burden on resources, lack of infrastructure, short-lasting decrease in morbidity and lack of cost-effectiveness data limits its wide applicability. It is our routine departmental practice of performing limited neck dissection clearing level I-III/IV sparing level IIb which is cleared only if level IIa is metastatic. It is hypothesized that limited END would limit the morbidity of shoulder dysfunction and be a more feasible and cost-effective treatment option which could be a suitable alternative to SNB in this setting without compromising the survival outcomes. With this background, we propose to embark upon a phase III RCT comparing the oncologic outcomes and morbidity of SNB versus limited END. We hypothesize that limited END would have survival outcomes non-inferior, morbidity similar to SNB with higher cost-effectiveness.
Aims and objectives:
Aim To compare the survival outcomes, morbidity and cost-effectiveness of SNB versus limited END in node-negative early oral cancers
Primary objective
- Overall survival
Secondary objectives
- Shoulder morbidity (key secondary endpoint) longitudinally up to 2 years
- Disease-free survival
- Neck nodal recurrence-free survival
- Other side effects (chyle leak, hematoma, lymphoedema)
- Longitudinal Quality of life up to 2 years
- Cost-effective analysis
Exploratory objectives Blood and tumour tissue will be collected and banked for biomarker studies. Exploratory analyses will be conducted at a later date. Efforts may be directed to identify the biomarkers to predict nodal metastasis.
- Conditions
- Mouth Neoplasms, Oral Cancers, Oral Squamous Cell Carcinoma (OSCC), Oral Squamous Cell Carcinomas, Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy (SLNB)
- Being tested
- Sentinel Node Biopsy, Limited Elective Neck Dissection
- Keywords
- mouth neoplasms, neck dissection, sentinel lymph node biopsy, survival, morbidity, oral cancers, oral squamous cell carcinoma
- Medical subject headings
- Mouth Neoplasms, 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.
Sentinel Node BiopsyProcedure or surgery
The Sentinel node will be localized after injecting peritumoral nano colloid followed by dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization. Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel node will be processed on a frozen section, histopathological processing with serial step sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or second-stage completion neck dissection will be performed.
Limited Elective Neck DissectionProcedure or surgery
Patients who are allocated to the limited END arm will undergo dissection of level I, IIa and III/IV nodes sparing level IIb. Level IIa will be subjected to a frozen section and if reported as metastatic will mandate clearance of level IIb.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel node biopsy | Active comparator | Not described Receives: Procedure: Sentinel Node Biopsy |
| Limited elective neck dissection | Experimental | Not described Receives: Procedure: Limited Elective Neck Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Defined from the date of randomization to death due to any cause
Measured: 3 years
Secondary outcomes (6)
Shoulder morbidity
It will be assessed using the neck dissection impairment index (NDII). The range of movement of the shoulder will also be assessed using a goniometer
Measured: Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment
Neck nodal recurrence
Defined from the date of randomization to isolated neck node recurrence or death due to any cause
Measured: 3 years
Disease free survival
Defined from the date of randomization to any recurrence (local, regional or distant metastasis) and second primary in the oral cavity
Measured: 3 years
Health related Quality of life
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 and QLQ HN35 instruments
Measured: Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment
Adverse events related to the surgical procedure and lymphedema
Details of the intra and perioperative delay including injury to critical structures, chyle leak, haemorrhage, and head and neck lymphedema
Measured: The lymphedema rating will be done at 3 months, at 6 months, 12 months and 24 months of treatment
Cost effectiveness
Based on direct cost comparison
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start16 Apr 2025
- Primary completionApr 2032 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mouth NeoplasmsStudies 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
- Masking
- None (open label)
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- Tata Memorial Centre
- Responsible party
- Principal investigator, Richa Vaish, Tata Memorial Hospital
- Investigators
- Richa Vaish, MS, M.Ch, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774483
- Sponsor's protocol ID
- 4081
- Acronym
- SECOND N0
- Status last verified
- Oct 2024
- First submitted
- 7 Mar 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
PubMed 33052754D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
PubMed 26027881Hutchison IL, Ridout F, Cheung SMY, Shah N, Hardee P, Surwald C, Thiruchelvam J, Cheng L, Mellor TK, Brennan PA, Baldwin AJ, Shaw RJ, Halfpenny W, Danford M, Whitley S, Smith G, Bailey MW, Woodwards B, Patel M, McManners J, Chan CH, Burns A, Praveen P, Camilleri AC, Avery C, Putnam G, Jones K, Webster K, Smith WP, Edge C, McVicar I, Grew N, Hislop S, Kalavrezos N, Martin IC, Hackshaw A. Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. Br J Cancer. 2019 Nov;121(10):827-836. doi: 10.1038/s41416-019-0587-2. Epub 2019 Oct 15.
PubMed 31611612Dhar H, Vaish R, D'Cruz AK. Comment on "Nationwide randomised trial evaluating elective neck dissection for early-stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort.". Br J Cancer. 2020 Sep;123(7):1198-1199. doi: 10.1038/s41416-020-0981-9. Epub 2020 Jul 16. No abstract available.
PubMed 32669674Vaish R, Hawaldar R, Gupta S, Dandekar M, Shah S, Chaukar D, Pantvaidya G, Deshmukh A, Chaturvedi P, Pai P, Nair D, Nair S, Thakur M, Ghosh-Laskar S, Agarwal JP, D'Cruz AK. N0 neck trial: Does intensification of follow-up (Ultrasound + Physical Examination) influence outcomes in early-stage oral cancer? Eur J Cancer. 2024 Jun;204:114064. doi: 10.1016/j.ejca.2024.114064. Epub 2024 Apr 16.
PubMed 38705028
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial
- ClinicalTrials.gov ID
- NCT05774483
- Acronym / sponsor ID
- SECOND N0 / 4081
- Conditions
- Mouth Neoplasms, Oral Cancers, Oral Squamous Cell Carcinoma (OSCC), Oral Squamous Cell Carcinomas, Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy (SLNB)
- Keywords
- mouth neoplasms, neck dissection, sentinel lymph node biopsy, survival, morbidity, oral cancers, oral squamous cell carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- Tata Memorial Centre
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 17 Mar 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.
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers.
The main questions it aims to answer are:
- Survival outcomes
- Morbidity outcomes
- Cost-effectiveness
Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.
Detailed description
Based on the current literature, we know that elective neck dissection (END) is mandatory in clinically node-negative early oral cancers. However, this leads to overtreatment and morbidity in about 55-80% of patients. The emergence of recent level I evidence makes SNB the standard of care in this setting. However, its limitation of being a two-staged procedure, steep learning curve, the burden on resources, lack of infrastructure, short-lasting decrease in morbidity and lack of cost-effectiveness data limits its wide applicability. It is our routine departmental practice of performing limited neck dissection clearing level I-III/IV sparing level IIb which is cleared only if level IIa is metastatic. It is hypothesized that limited END would limit the morbidity of shoulder dysfunction and be a more feasible and cost-effective treatment option which could be a suitable alternative to SNB in this setting without compromising the survival outcomes. With this background, we propose to embark upon a phase III RCT comparing the oncologic outcomes and morbidity of SNB versus limited END. We hypothesize that limited END would have survival outcomes non-inferior, morbidity similar to SNB with higher cost-effectiveness.
Aims and objectives:
Aim To compare the survival outcomes, morbidity and cost-effectiveness of SNB versus limited END in node-negative early oral cancers
Primary objective
- Overall survival
Secondary objectives
- Shoulder morbidity (key secondary endpoint) longitudinally up to 2 years
- Disease-free survival
- Neck nodal recurrence-free survival
- Other side effects (chyle leak, hematoma, lymphoedema)
- Longitudinal Quality of life up to 2 years
- Cost-effective analysis
Exploratory objectives Blood and tumour tissue will be collected and banked for biomarker studies. Exploratory analyses will be conducted at a later date. Efforts may be directed to identify the biomarkers to predict nodal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel node biopsy | Active comparator | Procedure: Sentinel Node Biopsy |
| Limited elective neck dissection | Experimental | Procedure: Limited Elective Neck Dissection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years of age
- Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM 8 edition
- Clinicoradiologically node negative
- Amenable to per oral excision
Key exclusion criteria (5 listed)
- Previous surgery in the head and neck region,
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesions
- Previous malignancy in the head and neck region
- Patients requiring the free flap reconstruction
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 |
|---|---|---|
| Sentinel Node BiopsyThe Sentinel node will be localized after injecting peritumoral nano colloid followed by dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization. Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel node will be processed on a frozen section, histopathological processing with serial step sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or second-stage completion neck dissection will be performed. | Procedure or surgery | Sentinel node biopsy |
| Limited Elective Neck DissectionPatients who are allocated to the limited END arm will undergo dissection of level I, IIa and III/IV nodes sparing level IIb. Level IIa will be subjected to a frozen section and if reported as metastatic will mandate clearance of level IIb. | Procedure or surgery | Limited elective neck dissection |
Primary outcome
Overall survival
Time frame: 3 years
Defined from the date of randomization to death due to any cause
6 secondary outcomes
Shoulder morbidity
Time frame: Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment
Neck nodal recurrence
Time frame: 3 years
Disease free survival
Time frame: 3 years
Health related Quality of life
Time frame: Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment
Adverse events related to the surgical procedure and lymphedema
Time frame: The lymphedema rating will be done at 3 months, at 6 months, 12 months and 24 months of treatment
Cost effectiveness
Time frame: 3 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 17 Jul 2025.
- Background: PubMed 33052754Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
- Background: PubMed 26027881D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
- Background: PubMed 31611612Hutchison IL, Ridout F, Cheung SMY, Shah N, Hardee P, Surwald C, Thiruchelvam J, Cheng L, Mellor TK, Brennan PA, Baldwin AJ, Shaw RJ, Halfpenny W, Danford M, Whitley S, Smith G, Bailey MW, Woodwards B, Patel M, McManners J, Chan CH, Burns A, Praveen P, Camilleri AC, Avery C, Putnam G, Jones K, Webster K, Smith WP, Edge C, McVicar I, Grew N, Hislop S, Kalavrezos N, Martin IC, Hackshaw A. Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. Br J Cancer. 2019 Nov;121(10):827-836. doi: 10.1038/s41416-019-0587-2. Epub 2019 Oct 15.
- Background: PubMed 32669674Dhar H, Vaish R, D'Cruz AK. Comment on "Nationwide randomised trial evaluating elective neck dissection for early-stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort.". Br J Cancer. 2020 Sep;123(7):1198-1199. doi: 10.1038/s41416-020-0981-9. Epub 2020 Jul 16. No abstract available.
- Background: PubMed 38705028Vaish R, Hawaldar R, Gupta S, Dandekar M, Shah S, Chaukar D, Pantvaidya G, Deshmukh A, Chaturvedi P, Pai P, Nair D, Nair S, Thakur M, Ghosh-Laskar S, Agarwal JP, D'Cruz AK. N0 neck trial: Does intensification of follow-up (Ultrasound + Physical Examination) influence outcomes in early-stage oral cancer? Eur J Cancer. 2024 Jun;204:114064. doi: 10.1016/j.ejca.2024.114064. Epub 2024 Apr 16.
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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.
Richa Vaish, MS, M.Ch principal investigator
Tata Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Node Biopsy and Limited Elective Neck Dissection in people with Mouth Neoplasms and Oral Cancers, run by Tata Memorial Hospital at 3 sites in India.
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 5 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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?
Contact Richa Vaish, MS, M.Ch (02224177000 ext. 7238, drvaishricha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774483, which also lists 5 linked publications.
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 17 Jul 2025.