Surgical resectable: T2-3, N0-1, M0 adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus
Conditions
Interventions
Product Name: carboplatin
Pharmaceutical Form: Intravenous infusion
Product Name: paclitaxel
Pharmaceutical Form: Intravenous infusion
Product Name: panitumumab
Product Code: AMG954
Pharmaceutical F
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus •Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS). •T1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible •Tumor length longitudinal = 10 cm and radial = 5 cm •If tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach. Gastric cancers with minor involvement of the GE junction or distal esophagus are not eligible •No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula •Non pregnant, non-lactating female patients. •Age = 18 and = 75 •ECOG performance status 0, 1, or 2 •Adequate hematological, renal, hepatic and pulmonary functions defined as: granulocytes = 1.5 x 109/L platelets = 100 x 109/L total bilirubin = 1.5 x upper normal limit creatinine = 120 µmol/L FEV1 = 1.5 L •Written, voluntary informed consent •Patients must be accessible to follow up and management in the treatment center Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment. •Previous chemotherapy, radiotherapy, treatment with a an anti-EGFR antibody or with small molecule EGFR inhibitors •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before randomization •Pre-existing motor or sensory neurotoxicity greater than WHO grade 1 •Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine •Dementia or altered mental status that would prohibit the understanding and giving of informed consent •Inadequate caloric- and/or fluid intake • Weight loss > 15%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 our trial we 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. ;Secondary Objective: To evaluate the toxicity, progression free survival, median survival rate and the R0 resection rate.;Primary end point(s): Percentage of pathologic complete responses | — |
Countries
Netherlands
Outcome results
None listed