Comparing Two Neck Procedures for Early Mouth Cancer Without Spread
Compares sentinel node biopsy with limited neck dissection in adults with early mouth cancer.
Plain-language title generated from the registry record
Registry title: Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
Key facts
- Where
- Mumbai, Navi Mumbai, and Varanasi, IndiaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05774483, who can take part
Where in India
- Tata Memorial HospitalMumbai, IndiaTaking people
- ACTRECNavi Mumbai, IndiaNot yet recruiting
- Mpmmcc & HbchVaranasi, IndiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tata Memorial Hospital
- Trial code
- NCT05774483
- Record updated
- 17 July 2025
- Original description
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.Read full original descriptionShow less
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III 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.
Inclusion: 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.
Exclusion: Previous surgery in the head and neck region,; Previous malignancy in the head and neck region; Upper alveolar or palatal lesions; Large heterogeneous leukoplakia or other premalignant lesions; Patients requiring the free flap reconstruction.