Comparing two surgical approaches for early mouth cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.