Chemoradiation followed by surgery for patients with cT4 oesophageal cancer
- Conditions
- 1001799010017998oesophageal carcinomaoesophagus cancer
- Registration Number
- NL-OMON38001
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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)
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) <= 1 year before enrollment
Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
Dementia or altered mental status that would prohibit the understanding and giving of informed consent
Inadequate caloric- and/or fluid intake
Weight loss > 15%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The ability to achieve a radical (R0) resection.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Toxicity profile<br /><br>• Adequacy of PET-CT and EUS in (re-)staging T4 oesophagus carcinoma<br /><br>• Peri-operative morbidity and mortality<br /><br>• Percentage of pathologic complete responses<br /><br>• Progression free survival at 6 months</p><br>