Chemoradiation combined with panitumumab followed by surgery for patients with operable esophageal cancer

Phase 2

Conditions: cancer of the esophagus
10017991

Registration Number: NL-OMON35643

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 76

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 *mol/L
FEV1 * 1.5 L
*Written, voluntary informed consent
*Patients must be accessible to follow up and management in the treatment center

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%.