NCT05774483Recruiting
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 508 (estimated)
- First submitted
- 7 Mar 2023
- Start date
- 16 Apr 2025
- Primary completion date
- Apr 2032
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT05774483
What you commit to
- Study type: Interventional
- Planned participants: 508
- From 16 Apr 2025 to the primary completion date, Apr 2032
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgery in the head and neck region,
Other illness
- Previous malignancy in the head and neck region
Other
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesions
- Patients requiring the free flap reconstruction
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| ACTREC Coordinator of this site? Confirm its status | Navi Mumbai | India | Not yet recruiting |
| Mpmmcc & Hbch Coordinator of this site? Confirm its status | Varanasi | India | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.