Trial information
A Study of Tarceva (Erlotinib) in Patients With Resected Head and Neck Squamous Cell Cancer.
Status: Recruiting
Protocol number: ML20294
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label, study of the effect of Tarceva on progression free survival when given as maintenance treatment following concurrent chemo-radiotherapy or radiotherapy alone in patients with resected head and neck squamous cell cancer
Brief summary: This 2 arm study will compare the efficacy and safety of Tarceva, versus standard of care, in patients with resected head and neck squamous cell cancer who are receiving concurrent chemo-radiotherapy or radiotherapy alone. Patients will be randomized to receive either Tarceva 150mg po daily or standard of care. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Head and Neck Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall survival Time frame: Event driven
2. AEs Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- high risk totally resected head and neck squamous cell cancer: T3-T4 or N2-N3;
- ECOG <=2.
Exclusion criteria:
- macroscopic residual disease after surgery;
- previous treatment with anti-EGFR.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2006
Trial registration date: 12/18/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Alcorcon
- Barcelona
- Burgos
- Córdoba
- Granada
- Guadalajara
- Jaen
- Lugo
- Madrid
- Murcia
- Orense
- Palma de Mallorca
- Salamanca
- San Sebastian
- Santander
- Sevilla
- Toledo
- Valencia
- Zamora
- Zaragoza
