Health Condition 1: null- Oral Cancer with Neck node metastases
Conditions
Interventions
Intervention1: Selective Neck dissection: Surgical Procedure for clearing lymph nodes from the neck
Control Intervention1: Modified Radical Neck Dissetion: Surgical technique for clearing lymph nodes
Sponsors
Head and Neck Coperative Oncology Froup
Eligibility
Inclusion criteria
Inclusion criteria: 1)The subject has a histologically confirmed squamous cell carcinoma of the oral cavity 2)The subjects age must be between 18 and 75 years 3)The subjects life expectancy is greater than 12 weeks and ECOG performance status 0 or 1 4)The subject has signed and dated the written informed consent 5)The subject is willing and able to fully participate for the duration of the study 6)If applicable, the subject has been counselled on tobacco cessation 7)Subjects are candidates for surgical intervention as determined by the anaesthesiologist of the institution at which he is undergoing treatment
Exclusion criteria
Exclusion criteria: 1)The subject has neck nodes on both sides of the neck, classified as N2c as per the AJCC Cancer Staging Manual 2010 OR neck nodes greater than 6cm in size, classified as N3 disease 2)The biopsy of the primary disease in the subject is a histology other than squamous cell carcinoma 3)The subject has a synchronous primary located in the upper aerodigestive tract or cancer of any other site 4)The subject has confirmed metastatic disease at initial clinical evaluation or during investigations 5)The subject is deemed not fit for surgeries due to medical conditions 6)The subject has received any previous surgery, radiotherapy or chemotherapy as treatment for his disease 7)The subject is not fit to receive radiation therapy due to personal choice, logistical reasons, or medical reasons 8)The subjects primary disease is localised to one side of the head and neck and is crossing the midline 9)The subject has nodal metastasis in levels IV or V 10) Subjects with pa st history of psychological illness seriously affecting the subjectâ??s ability to give an informed consent 11) The subject is, in the opinion of the Institutional Principal Investigator, not an appropriate candidate for study participation 12) The subject has participated in the study previously and was withdrawn 13) Screen Failure: All subjects considered for participation and found ineligible must be recorded in the Screen Failure Log. Subject confidentiality is maintained, but reason for exclusion is required. 14) The subject is part of another active clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Regional control rates in patients with node positive oral squamous cell carcinoma undergoing either selective neck dissection or the standard modified radical neck dissectionTimepoint: 2 years after completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Recurrence free and overall survival in both arms 2)Incidence of level V metastasis among patients of oral squamous cell carcinoma 3)Quality of life among patients in both arms 4)Shoulder morbidity index between the two arms of the study Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Pattatheyil Arun
Tata Medical Center,Kolkata
Outcome results
None listed