Status:
UNKNOWN
Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Oral Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these can...
Detailed Description
Stratification criteria: 1. Size 2. Sex 3. Site 4. Sonography Randomization (I): All patients will be randomly allocated into one of two arms: wait and watch policy group or elective neck dissection...
Eligibility Criteria
Inclusion
- Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
- Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
- No history of a prior malignancy in the head and neck region.
- No prior malignancy outside the head and neck region in the preceding 5 years.
- Patient will be reliable for follow-up
- Age\> 18 years and \< 75 years.
- No significant co-morbid conditions - ASA grade II and I.
- Understands the protocol and is able to give informed consent.
Exclusion
- Prior radiotherapy or surgery for malignancy in the head and neck region.
- Non squamous cell carcinomas of the oral cavity.
- Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
- Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT00193765
Start Date
January 1 2004
End Date
June 1 2019
Last Update
June 16 2017
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012