drugset / Trial / NCT01884259

Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

NCT01884259 ↗

Phase 2 Completed 100 enrolled Study Group of Medical Tumour Therapy (AGMT)
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

Timeline

Start
2013-05
Primary completion
2021-01-28
Completion
2022-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 —
Comparator fluorouracil Small molecule 750 mg/m2 —
Background Cisplatin Other / unclassified 75 mg/m2 —
Background Docetaxel Small molecule 75 mg/m2 —