drugset / Trial / NCT01566435

Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer

NCT01566435 ↗

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.

Timeline

Start
2012-08-09
Primary completion
2013-10-31
Completion
2019-10-31

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper This exploratory retrospective comparative analysis demonstrated no significant difference in CIDD, OS, or cumulative incidence of relapse between patients treated with APF-C or APF. PMID 28797458 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 100 mg/m2 —
Subject fluorouracil Small molecule 750 mg/m2 —