PDL-1 targeting in resectable oesophageal cancer: a phase II feasibility study of Atezolizumab and chemoradiation (PERFECT)
Phase 2
Recruiting
- Conditions
- 10017991Esophageal cancer
- Registration Number
- NL-OMON55613
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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
Past or current history of malignancy other than entry diagnosis interfering
with prognosis of esophageal cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is feasibility defined as percentage completion of<br /><br>treatment with atezolizumab. Patients that do not complete treatment with<br /><br>atezolizumab for reasons other than toxicity will be replaced and not included<br /><br>in the analysis of the primary end point. </p><br>
- Secondary Outcome Measures
Name Time Method <p> Secondary endpoints are:<br /><br>• Incidence and severity of toxicity defined according to CTCAE v4.03 and<br /><br>Radiation Oncology Group (RTOG) criteria.<br /><br>• Percentage completion of chemotherapy and radiation treatment<br /><br>• Percentage withdrawal rate from surgery<br /><br>• Incidence and severity of post-operative complications according to the Dindo<br /><br>classification.<br /><br>• Pathological response according to the Mandard criteria.<br /><br>• R0 resection rate.<br /><br>• Progression free survival<br /><br>• Overall survival<br /><br><br /><br>Exploratory endpoints are:<br /><br>• Potential biomarker development based on assessment of tumour biopsies,<br /><br>faeces and blood samples and the proposed mechanism of action of study<br /><br>drugs.</p><br>