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
Sponsors and collaborators
Tata Memorial Hospital
Lead sponsor
Tata Memorial Centre
Collaborator