drugset / Trial / NCT00959387

Induction Chemotherapy for Advanced Head and Neck Cancer

NCT00959387 ↗

Phase 2 Completed 60 enrolled Barretos Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2009-08
Primary completion
2010-11
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 80 mg/m2 Other
Subject Paclitaxel Small molecule 175 mg/m2 Other

Indications