Clinical trial · Interventional
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial
NCT05774483CI-TRIAL-00092274SECOND N0recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
| Oral Cancers | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
| Oral Squamous Cell Carcinomas | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Limited Elective Neck Dissection | Procedure | — | UNRESOLVED |
| Sentinel Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sentinel node biopsy
- interventionNames
- Procedure: Sentinel Node Biopsy
- type
- EXPERIMENTAL
- label
- Limited elective neck dissection
- interventionNames
- Procedure: Limited Elective Neck Dissection
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 years
- description
- Defined from the date of randomization to death due to any cause
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 years of age 2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa 3. T1 and T2 lesions as per AJCC TNM 8 edition 4. Clinicoradiologically node negative 5. Amenable to per oral excision 6. Treatment naïve 7. No other site of malignancy Exclusion Criteria: 1. Previous surgery in the head and neck region, 2. Upper alveolar or palatal lesions 3. Large heterogeneous leukoplakia or other premalignant lesions 4. Previous malignancy in the head and neck region 5. Patients requiring the free flap reconstruction
References
Publications (5)
- BACKGROUNDGarrel 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. PMID 33052754
- BACKGROUNDD'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. PMID 26027881
- BACKGROUNDHutchison 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. PMID 31611612
- BACKGROUNDDhar 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. PMID 32669674
- BACKGROUNDVaish 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.