Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

NCT05774483 | Recruiting

• 1 other identifier: 4081
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 3

Brief 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. 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

Mouth Neoplasms; Oral Cancers; Oral Squamous Cell Carcinoma (OSCC); Oral Squamous Cell Carcinomas; Sentinel Lymph Node Biopsy; Sentinel Lymph Node Biopsy (SLNB); Sentinel Lymph Node

Keywords

mouth neoplasms; neck dissection; sentinel lymph node biopsy; survival; morbidity; oral cancers; oral squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Defined from the date of randomization to death due to any cause

  3 years

Secondary Outcomes (6)

• Shoulder morbidity

  Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment

• Neck nodal recurrence

  3 years

• Disease free survival

  3 years

• Health related Quality of life

  Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment

• Adverse events related to the surgical procedure and lymphedema

  The lymphedema rating will be done at 3 months, at 6 months, 12 months and 24 months of treatment

Study Arms (2)

Sentinel node biopsy

ACTIVE COMPARATOR

Procedure: Sentinel Node Biopsy

Limited elective neck dissection

EXPERIMENTAL

Procedure: Limited Elective Neck Dissection

Interventions

Sentinel Node Biopsy PROCEDURE

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.

Sentinel node biopsy

Limited Elective Neck Dissection PROCEDURE

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.

Limited elective neck dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Tata Memorial Centre: collaborator

Study Sites (3)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

ACTREC

Navi Mumbai, Maharashtra, India

NOT YET RECRUITING

Mpmmcc & Hbch

Varanasi, Uttar Pradesh, India

NOT YET RECRUITING

Related Publications (5)

• 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.

  PMID: 33052754 BACKGROUND

• D'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 BACKGROUND

• Hutchison 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 BACKGROUND

• Dhar 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 BACKGROUND

• Vaish 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.

  PMID: 38705028 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Richa Vaish, MS, M.Ch

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richa Vaish, MS, M.Ch

CONTACT

02224177000; drvaishricha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Surgeon

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: April 16, 2025
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2034
• Last Updated: July 17, 2025

Record last verified: 2024-10

Locations

IN (3)