Head and Neck Cancer Clinical Trial
Official title:
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).
Over the last 30 years, induction chemotherapy (IC) has become important for the management
of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of
taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF
regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with
the PF regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most
accepted induction regimen for the treatment of LAHNSCC.
However, the TPF regimen has been associated with high toxicity rates, and patients
frequently decline cisplatin during concurrent radiotherapy and require the use of infusion
pumps and a central venous catheter.
Extensive efforts are ongoing to identify alternative schemes that are less toxic than the
TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive
concurrent treatment based on cisplatin and radiotherapy.
This non-randomized phase II trial evaluated the safety, feasibility and response rates of
concurrent therapy (cisplatin and radiotherapy) after three cycles of an IC regimen based on
the combination of cisplatin plus paclitaxel without 5-fluorouracil (5FU) (thereby avoiding
infusion pumps and a central venous catheter) in LAHNSCC patients with a high tumor burden.
The patients were stratified by tumor subsite (oropharynx and hypopharynx/larynx) and by
tumor resectable status (resectable or irresectable advanced squamous cell).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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