NCT05774483 Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
| NCT ID | NCT05774483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Hospital |
| Condition | Mouth Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 508 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2032-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 508 participants in total. It began in 2025-04-16 with a primary completion date of 2032-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Richa Vaish, MS, M.Ch
PRINCIPAL INVESTIGATOR
Tata Memorial Hospital
Frequently Asked Questions
Who can join the NCT05774483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Mouth Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05774483 currently recruiting?
Yes, NCT05774483 is actively recruiting participants. Contact the research team at drvaishricha@gmail.com for enrollment information.
Where is the NCT05774483 trial being conducted?
This trial is being conducted at Mumbai, India, Navi Mumbai, India, Varanasi, India.
Who is sponsoring the NCT05774483 clinical trial?
NCT05774483 is sponsored by Tata Memorial Hospital. The principal investigator is Richa Vaish, MS, M.Ch at Tata Memorial Hospital. The trial plans to enroll 508 participants.