A Pilot Study With Cetuximab and Radiation Therapy for Patients With Surgically Resectable Esophageal and GE Junction Carcinomas: Hoosier Oncology Group Study (GI05-92)
OUTLINE: This is a multi-center study.
- Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose)
- Cetuximab 250 mg/m2 IV over 60 minutes, day -7.
- Cetuximab 250 mg/m2 IV over 60 minutes, days 1, 8, 15, 22, 29 and 36.
- External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost
of 540 cGy at 180 cGy per fraction for 6 weeks.
- Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes
by a transthoracic approach after satisfactory hematologic and functional recovery
within 8 weeks of completion of radiation therapy.
- For patients who give their consent, fresh frozen tissue will be obtained per EUS at
baseline, per EUS 2 weeks after the initiation of cetuximab, and at the time of surgery
for pathology submission.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
· To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas
Carlos Becerra, M.D.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Texas Southwestern Medical Center at Dallas||Dallas, Texas 75235-8897|
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|Texas Oncology, PA||Dallas, Texas 75246-2006|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Community Regional Cancer Center||Indianapolis, Indiana 46256|
|AP&S Clinic||Terre Haute, Indiana 47804|