Phase II Randomized Controlled Trial of Accelerated Fractionation Radiotherapy (6 Fractions Per Week) Versus Concurrent Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Concurrent chemo-radiotherapy is a common and conventional method of treating locally
advanced head and neck squamous cell carcinoma (HNSCC). In locally advanced HNSCC it has
been proved to be superior to radiotherapy alone. On the other side accelerated
fractionation radiotherapy (AFRT) is a proven practice to improve cure rate in head and neck
cancers. Yet it has not been compared with Concurrent Chemoradiotherapy (CRT) in locally
advanced HNSCC and hence this study is aiming to compare CRT versus AFRT.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
TO COMPARE THE LOCO-REGIONAL TUMOR CONTROL RATE BETWEEN AFRT & CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS.
To compare the loco-regional tumor control rate clinical assessment after 3months of treatment completion will be done.CECT of face and neck at 3 months post treatment completion will be done.
5months(2months treatment period followed by 3 months observation)
No
Dr SUDEEP DAS, MBBS
Principal Investigator
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA
INDIA:ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
RCTOFAFRTVSCRTINHNSCCAIIMS
NCT01291095
February 2011
December 2012
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