Chemoradiation and Panitumumab for Esophageal Cancer
Recruitment status was Recruiting
A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of better disease-free and overall survival. Therefore in the investigators trial the investigators will evaluate the pathologic response of panitumumab in combination with neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus.
Squamous Cell Carcinoma
Gastro-esophageal Junction Cancer
Radiation: 3-D conformal radiation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Chemoradiation Combined With Panitumumab Followed by Surgery for Patients With Operable Esophageal Cancer|
- Percentage of pathologic complete responses [ Time Frame: 6 weeks after the completion of the chemoradiation ] [ Designated as safety issue: No ]
- R0 resection rate [ Time Frame: the pathologist will determine the resection rate ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Every 3 months during the first 2 years after surgery, and every 6 months thereafter. ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: Weekly during chemoradiation. After surgery: every 3 months during the first 2 years after surgery, and every 6 months thereafter. ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||February 2011|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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 esophagus.
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.
|Contact: Hanneke Wilmink, MD PhDfirstname.lastname@example.org|
|Contact: Dick Richel, MD PhDemail@example.com|
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Hanneke Wilmink, MD PhD +31-20-5665955 firstname.lastname@example.org|
|Principal Investigator: Hanneke Wilmink, MD PhD|
|Principal Investigator:||Hanneke Wilmink, MD PhD||Academic Medical Center, Amsterdam|