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

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

Treatments tested in this trial

  • Sentinel Node Biopsy
  • Limited Elective Neck Dissection

Treatment groups

508 Participants
are divided into 2 treatment groups

Locations

3
Tata Memorial Hospital400012, MumbaiMaharashtra, India
ACTREC Navi MumbaiMaharashtra, India
Mpmmcc & Hbch VaranasiUttar Pradesh, India

Sponsors and collaborators

Tata Memorial Hospital

Lead sponsor

Tata Memorial Centre

Collaborator