oesophageal carcinoma oesophagus cancer
Conditions
Interventions
Chemotherapy regimen: Paclitaxel 50 mg/m2 and Carboplatin AUC = 2 will be given
by intravenous infusion on days 1, 8, 15, 22 and 29. This is the standard
regimen for definite chemoradiation therapy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction Surgical irresectable (T4a and T4b), as determined by Endoscopic Ultra Sound (EUS), CT scan of neck, thorax and abdomen OR Positon Emission Tomography (PET)-scan, without distant metastasis (T4a: ingrowth in pleura, pericardium, diaphragm, or adjacent peritoneum, T4b other adjacent structures,e.g. aorta, vertebral body, trachea)
Exclusion criteria
Exclusion criteria: cT4b oesophageal carcinoma with tracheobronchial involvement, as demonstrated on bronchoscopy after neoadjuvant treatment 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 Pregnancy (positive serum pregnancy test) and lactation Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 15%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ability to achieve a radical (R0) resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Toxicity profile • Adequacy of PET-CT and EUS in (re-)staging T4 oesophagus carcinoma • Peri-operative morbidity and mortality • Percentage of pathologic complete responses • Progression free survival at 6 months | — |
Countries
Netherlands
Outcome results
None listed