Chemoradiation and Panitumumab for Esophageal Cancer
Condition: Squamous Cell Carcinoma; Adenocarcinoma; Esophageal Cancer; Gastro-esophageal Junction Cancer
MeSH terms: Carcinoma, Squamous Cell; Adenocarcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Carboplatin; Paclitaxel; panitumumab; radiotherapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Carboplatin AUC = 2 , weekly.; Paclitaxel 50 mg/m2, weekly; panitumumab: 6mg/kg in weeks 1-3-5.; A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
Other intervention name(s): vectibix
Intervention MeSH terms: Paclitaxel; Carboplatin; Panitumumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chemoradiation; panitumumab; esophageal cancer; Resectable squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction