ECK DISSECTION VERSUS OBSERVATION IN EARLY ORAL CAVITY CANCER

Not Applicable

Conditions: Health Condition 1: null- T1, T2 oral cavity cancer with node negative neck

Registration Number: CTRI/2013/04/003568

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 710

Inclusion Criteria

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.

Exclusion Criteria

. 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e. therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.Timepoint: overall survival

Secondary Outcome Measures

Name	Time	Method
Does USG examination have any role in routine initial workup of node negative patient? How are patients followed up â??does USG have role or clinical examination sufficient. Is assessment of tumor thickness by surgeon at time of initial surgery accurate â??Is there correlation between tumor thickness as measured grossly by surgeon, at FS versus final HPR. Identify HPR prognostic factors in primary that may help identify sub-set of patients at increased risk of cervical metastasis.Timepoint: 5 years