Esophageal cancer
Conditions
Interventions
Atezolizumab is added once every three weeks to the standard chemoradation.
After 5 administrations surgery takes place.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically proven adenocarcinoma of the esophagus or gastro esophageal junc 2. The tumor is surgically resectable 3. Patient is fit for surgery
Exclusion criteria
Exclusion criteria: Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is feasibility defined as percentage completion of treatment with atezolizumab. Patients that do not complete treatment with atezolizumab for reasons other than toxicity will be replaced and not included in the analysis of the primary end point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: • Incidence and severity of toxicity defined according to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria. • Percentage completion of chemotherapy and radiation treatment • Percentage withdrawal rate from surgery • Incidence and severity of post-operative complications according to the Dindo classification. • Pathological response according to the Mandard criteria. • R0 resection rate. • Progression free survival • Overall survival Exploratory endpoints are: • Potential biomarker development based on assessment of tumour biopsies, faeces and blood samples and the proposed mechanism of action of study drugs. | — |
Countries
Netherlands
Outcome results
None listed