Overview

Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
The DeLOS II trial is a multicenter randomised phase II trial investigating a TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation.
Phase:
Phase 2
Details
Lead Sponsor:
ClinAssess
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
Treatments:
Cetuximab
Cisplatin
Docetaxel
Fluorouracil