Trial intelligence / Profile preview

Cetuximab with TPF Induction for Oropharyngeal Cancer

NCT00665392Phase 2

Key facts

Status: Completed
Start: Feb 2008
Primary completion: Feb 2012
Countries: 1
Sponsor: GERCOR
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: cetuximab
Conditions: squamous cell carcinoma of the oropharynx (OPSCC)

Overview

Phase 2, open-label, single-arm trial of cetuximab in squamous cell carcinoma of the oropharynx (OPSCC), sponsored by GERCOR. Primary endpoint: Clinical and Radiological Complete Clinical Response Rate at 3 months. Started Feb 2008; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Cetuximab + TPF
Induction chemotherapy with Cetuximab, Docetaxel, Cisplatin, and Fluorouracil followed by surgery.

Who it enrols

Patients with resectable Stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx, WHO performance status 0-1, and adequate organ function. Excludes patients with prior chemotherapy or radiotherapy, or serious cardiac/respiratory disease.

Endpoints

Primary

Clinical and Radiological Complete Clinical Response Rate3 months

Secondary

Complete Clinical Response3 months
Overall Survival2 years
Pathologic Responseafter surgery
Progression-Free Survival2 years
Complete Radiological Response3 months

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