Comparing two surgical approaches for early mouth cancers
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial
This study is testing whether a less invasive surgery for early mouth cancers can provide similar survival rates while being easier on patients and more affordable than the standard approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 508 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tata Memorial Hospital Government |
| Locations | 3 sites (Mumbai, Maharashtra and 2 other locations) |
| Trial ID | NCT05774483 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the survival outcomes, morbidity, and cost-effectiveness of sentinel node biopsy (SNB) versus limited elective neck dissection (END) in patients with early, node-negative oral cancers. Participants will be randomly assigned to either undergo SNB, which may involve a second procedure if metastasis is detected, or limited END, which selectively clears lymph nodes based on metastatic findings. The study seeks to determine if limited END can provide similar survival outcomes with reduced morbidity and better cost-effectiveness compared to SNB.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with biopsy-proven invasive squamous cell carcinoma of the tongue or buccal mucosa that is clinically node-negative.
Not a fit: Patients with previous head and neck surgeries, other malignancies, or those requiring complex reconstructive procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more cost-effective surgical option for patients with early oral cancers.
How similar studies have performed: Previous studies have shown promising results for sentinel node biopsy in similar contexts, but this comparison with limited elective neck dissection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years of age 2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa 3. T1 and T2 lesions as per AJCC TNM 8 edition 4. Clinicoradiologically node negative 5. Amenable to per oral excision 6. Treatment naïve 7. No other site of malignancy Exclusion Criteria: 1. Previous surgery in the head and neck region, 2. Upper alveolar or palatal lesions 3. Large heterogeneous leukoplakia or other premalignant lesions 4. Previous malignancy in the head and neck region 5. Patients requiring the free flap reconstruction
Where this trial is running
Mumbai, Maharashtra and 2 other locations
- Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)
- Actrec — Navi Mumbai, Maharashtra, India (Not_yet_recruiting)
- Mpmmcc & Hbch — Varanasi, Uttar Pradesh, India (Not_yet_recruiting)
Study contacts
- Principal investigator: Richa Vaish, MS, M.Ch — Tata Memorial Hospital
- Study coordinator: Richa Vaish, MS, M.Ch
- Email: drvaishricha@gmail.com
- Phone: 02224177000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.