carcinoma of the oesophagus oesophageal cancer
Conditions
Interventions
An active surveillance approach after completion of nCRT for carcinoma of the
oesophagus. In this SANO (i.e. Surgery As
Needed for Oesophageal cancer) approach, patients undergo active surveillance
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to CROSS, followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction;, Age >=18;, Written, voluntary, informed consent.
Exclusion criteria
Exclusion criteria: Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires;, Non-FDG-avid tumour at baseline PET-CT scan. Previous treatment with endoscopic resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression free survival, distant dissemination rate, and cost-effectiveness | — |
Countries
Netherlands
Outcome results
None listed