sentinel node biopsy versus limited neck dissection in node negative early oral cancer
Phase 3
- Conditions
- Health Condition 1: C02- Malignant neoplasm of other and unspecified parts of tongueHealth Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/05/052892
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 lesion as per AJCC TNM 8
th 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Overall survival <br/ ><br>Timepoint: 1) Overall survival 3 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)Shoulder morbidity (key secondary end point) longitudinally up to 2 years <br/ ><br>2) Disease free survival <br/ ><br>3) Neck nodal recurrence free survival <br/ ><br>4) Other side effects (chyle leak, hematoma, lymphoedema) <br/ ><br>5) Longitudinal Quality of life up to 2 year <br/ ><br>6) Cost effective analysisTimepoint: 1) At baseline before surgery, at 3,6,12 and 24 months after treatment <br/ ><br>2) 3 years <br/ ><br>3) 3 years <br/ ><br>4) intraoperative/ lymphedema at 3,6,12,24 months after treatment <br/ ><br>5) Baseline before surgery, 3,6,12,24 months after treatment <br/ ><br>6)3 years <br/ ><br>