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

ConditionsMouth NeoplasmsOral CancersOral Squamous Cell Carcinoma (OSCC)Oral Squamous Cell CarcinomasSentinel Lymph Node BiopsySentinel Lymph Node Biopsy (SLNB)Sentinel Lymph Node
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTata Memorial Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sentinel Node Biopsy

    Procedure/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 Dissection

    Procedure/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.

Treatment groups

508 Participants
are divided into 2 treatment groups
Group A: Sentinel node biopsyActive comparator 1 intervention
Group B: Limited elective neck dissectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

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

Time frame
3 years

Secondary outcomes

1

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

Time frame
Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment
2

Neck nodal recurrence

Defined from the date of randomization to isolated neck node recurrence or death due to any cause

Time frame
3 years
3

Disease free survival

Defined from the date of randomization to any recurrence (local, regional or distant metastasis) and second primary in the oral cavity

Time frame
3 years
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Hospital

Lead sponsor

Tata Memorial Centre

Collaborator

Source ClinicalTrials.gov
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