Chemoradiation Combined With Panitumumab Followed by Surgery for Patients With Operable Esophageal Cancer
This is a Phase II, non-randomized trial. Eligible subjects will be treated with panitumumab
plus carboplatin, paclitaxel and radiotherapy followed by surgical resection of the
Panitumumab administration schedule: Panitumumab will be administered as a 60-minute ± 15
minutes IV infusion, prior to administration of chemotherapy at a dose of 6 mg/kg on day 1,
15 and 29. If the first infusion is well tolerated (without any serious infusion related
reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.
Chemotherapy regimen: Paclitaxel 50 mg/m2 and Carboplatin AUC = 2 will be given by
intravenous infusion on days 1, 8, 15, 22 and 29. Both drugs will be infused over one hour.
Radiotherapy treatment: A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy, 5
fractions per week, starting the first day of the first cycle of chemotherapy. All patients
will be radiated by external beam radiation, using 3-D conformal radiation technique.
Surgery: Surgery will be performed preferably within 6 weeks after the completion of the
chemoradiation and panitumumab. For carcinomas distal of the tracheal bifurcation but
proximal to the gastro-esophageal junction, a transthoracic approach is preferred. For
distal tumors involving the gastro-esophageal junction a transhiatal esophageal resection is
preferred. A wide local excision including the N1 lymph nodes is carried out in both
techniques including a standard excision of the lymph nodes around the coeliac axis. The
continuity of the digestive tract will be restored by a gastric tube reconstruction or
colonic interposition procedure with an anastomosis in the neck.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of pathologic complete responses
6 weeks after the completion of the chemoradiation
Hanneke Wilmink, MD PhD
Academic Medical Center, Amsterdam
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)