Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma
- Assess the overall survival of older patients with stage I-IV squamous cell carcinoma
or adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib
hydrochloride in combination with radiotherapy.
- Assess the proportion of patients achieving mucosal complete response after treatment
with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Assess the effect of this regimen on dysphagia control, performance status, and overall
quality of life of these patients.
- Investigate the correlation between smoking status and overall survival of these
- To correlate the EGFR and phospho EGFR expression by IHC and EGFR mutation status with
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily for 1 year in the absence of
disease progression or unacceptable toxicity. Patients undergo external beam radiotherapy 5
days a week in weeks 1-4 or 5 days a week for the first 5.5 weeks.
Tumor tissue samples are analyzed by IHC for the expression of E-cadherin, P-cadherin,
vimentin, cytokeratin, phospho-S6, and Ki67.
After completion of study treatment, patients are followed at 30 days and annually
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Renuka Iyer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|