Induction Chemotherapy (IC) With Paclitaxel and Cisplatin (PC) Followed by Concomitant Chemoradiotherapy (CCRT) in Patient With Advanced Squamous Carcinoma of the Head and Neck (SSCHN).
A prospective unicenter phase-II trial will be performed to evaluate the effect of 3 cycles
of IC with PC followed by concomitant CCRT in locally advanced SSCHN.
The patients will be stratify by tumor subsite (oropharynx and hypopharynx/larynx)and by
resectable status (resectable or irresectable advanced squamous cell.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate
Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 60 days after completion fo chemoradiotherapy. Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.0).
2 years
Yes
Luciano S Viana, MSc
Principal Investigator
Brazilian Society of Clinical Oncology
Brazil: Ethics Committee
Barretos-01
NCT00959387
August 2009
April 2013
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