ELECTIVE VERSUS THERAPEUTIC NECK DISSECTION IN THE TREATMENT OF EARLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY - N0 Trial

Tata Memorial Hospital0 个研究点目标入组 710 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
•2. Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
•3. No history of a prior malignancy in the head and neck region.
•4. No prior malignancy outside the head and neck region in the preceding 5 years.
•5. Patient will be reliable for follow-up
•6. Age > 18 years and < 75 years.
•7. No significant co-morbid conditions - ASA grade II and I.
•8. Understands the protocol and is able to give informed consent.

•. Prior radiotherapy or surgery for malignancy in the head and neck region.
•2. Non squamous cell carcinomas of the oral cavity.
•3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
•4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
•5. Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.

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