Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
Specific Aims To determine the recurrence-free survival (primary endpoint), overall
survival, local and distant recurrence-free survival, and treatment-related toxicities.
Also, the investigators plan to study EGFR-related and immune biomarkers in baseline tumor
tissue as well as blood samples obtained prior and after therapy.
Subject Population We will enroll patients with completely resected, locally advanced
salivary gland cancers.
Treatment Plan Standard radiation 64-70Gy with 2.0 Gy daily fractions in 6-7 weeks.
Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-7 doses).
Statistical Design and Sample Size Phase II, one-stage, study with the 3-year
recurrence-free survival (RFS) as the primary endpoint. The sample size is 30 patients.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the recurrence-free survival of locoregionally-advanced (stages III/IV) salivary gland cancer patients undergoing postoperative chemoradiotherapy with panitumumab compared to historical control data. Survival measured by RECIST criteria and analyzed using the Kaplan-Meier method.
Athanassios Argiris, MD
University of Texas Health Science Center San Antonio
United States: Food and Drug Administration
|Cancer Therapy and Research Center at UTHSCSA||San Antonio, Texas 78229|