Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (PRESANO trial)
Completed
- Conditions
- carcinoma of the oesophagusoesophageal cancer100179911001799810017990
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 215
Inclusion Criteria
- Planned to undergo neoadjuvant chemoradiotherapy according to CROSS, followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma
- Age >= 18
- Written, voluntary informed consent
Exclusion Criteria
- Dementia or altered mental status prohibiting the understanding and giving of informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint<br /><br>• Correlation between the clinical response during CRE-I and CRE-II (CRE=<br /><br>clinical response evaluation) and the final pathological response in the<br /><br>resection specimen as measured by the modified tumour regression grading system<br /><br>of Chirieac (Cancer 2005). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br>• Serious complications during endoscopic and endosonographic tissue sampling<br /><br>(conventional biopsies and FNA).<br /><br>• R0-resection rates for all included patients that undergo resection.<br /><br><br /><br>Other important measurements that will be registered<br /><br>Further details per individual diagnostic modality will be registered and<br /><br>correlated with pathological findings in the resection specimen<br /><br>• Endoscopic examinations<br /><br>• Endoscopic ultrasonography (EUS) examinations<br /><br>• PET-CT<br /><br>• Analysis of (cyto)histological biopsies </p><br>