oesophageal adenocarcinoma
Conditions
Interventions
addition of pre-operative cetuximab/ radiotherapy
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction ;2) Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gasto-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.;3) Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained. Informed consent should be obtained before start of pre-operative chemotherapy treatment.;4) Weight loss
Exclusion criteria
Exclusion criteria: 1) Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ or any other malignancy with minimal chance of recurrence that has been treated with curative intent more than 5 years before start of study. 2) Inadequate organ function as defined by: - Inadequate haematology (Hb 1,5*ULN - ASAT > 2,5*ULN * ALAT > 2,5*ULN) or - Impaired renal function (creatinine clearance by Cockroft 1,0gr/24hr or urine protein stick 8 cm and/or > 5 cm radially 4) Major surgery within 4 weeks prior to the start of study treatment 5) Bleeding disorder 6) Known allergy to cetuximab 7) Previous radiotherapy to the chest 8) Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments 9) Continuous use of immunosuppressive agents 10) Prior exposure to anti-EGFR targeting agents. 11) Pregnancy or breast feeding 12) Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point of this study will be the pathologic complete remission (pCR) rate after pre-operative therapy and operability. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary end-points we defined safety of the procedure, progression free and overall survival, local recurrence rate and distant metastasis frequency, R0 resection rate, translational research to obtain more in-depth information on therapy response modifiers and feasibility of the study treatment. | — |
Countries
Netherlands
Outcome results
None listed