European iNvestigation of SUrveillance After Resection for Esophageal Cancer (ENSURE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03461341|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
The ENSURE study will comprise two phases.
Phase 1: European multicenter survey of surveillance protocols after esophageal cancer surgery
ENSURE questionnaire will be circulated to representatives from participating European countries.
Phase 2: European multicenter retrospective observational study of the impact of postoperative surveillance protocols on oncologic outcome and HR-QL
Phase 2 will constitute a retrospective observational study of patients undergoing treatment with curative intent for esophageal cancer at participating Centers from June 2009 to June 2015.
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Metastatic Cancer Recurrent Esophageal Cancer Chemoradiation Chemotherapy Radiation Surgery||Other: High intensity postoperative oncologic surveillance|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||ENSURE: European iNvestigation of SUrveillance After Resection for Esophageal Cancer|
|Actual Study Start Date :||June 1, 2009|
|Actual Primary Completion Date :||June 1, 2015|
|Estimated Study Completion Date :||April 1, 2019|
Patients post curative intent surgery for esophageal cancer
Patients post potentially curative surgery for cTxNxM0 esophageal or esophagogastric junction (Siewert type I, II and III) cancer.
Other: High intensity postoperative oncologic surveillance
High intensity surveillance protocol using routine cross-sectional imaging (computed tomography or positron emission tomography with computed tomography).
- Overall survival (months) [ Time Frame: Minimum 3 year follow-up for all patients ]Overall survival in months will be compared by Kaplan-Meier methods and using multivariable Cox proportional hazards regression, adjusting for known prognostic factors, to determine the independent impact of high intensity surveillance on survival outcome.
- Disease-specific survival (months) [ Time Frame: Minimum 3 year follow-up for all patients ]Disease-specific survival in months will be compared by Kaplan-Meier methods and using multivariable Cox proportional hazards regression, adjusting for known prognostic factors, to determine the independent impact of high intensity surveillance on survival outcome.
- Utilisation of routine surveillance imaging across European Centers [ Time Frame: 2009 - 2015 ]The proportion of European Centers utilising routine postperative oncologic surveillance imaging will be determined by email survey.
- Isolated solid organ metastasis (ISOM) at first recurrence [ Time Frame: Minimum 3 year follow-up for all patients ]Proportion of patients in high intensity versus standard surveillance groups with ISOM at first recurrence.
- Isolated local recurrence (ILR) at first recurrence [ Time Frame: Minimum 3 year follow-up for all patients ]Proportion of patients in high intensity versus standard surveillance groups with ILR at first recurrence.
- Health-related quality of life (HR-QL) as assessed by EORTC QLQ-C30 questionnaire [ Time Frame: At one year postoperatively ]"Overall health" score among disease-free patients at least one year postoperatively compared between high intensity and standard surveillance groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461341
|Department of Surgery, St. James's Hospital|
|Dublin, Ireland, D4|
|Department of Surgery and Cancer, 10th Floor, QEQM building, St. Mary's Hospital|
|London, United Kingdom, W21NY|
|Principal Investigator:||John V Reynolds, MD FRCS||St. James's Hospital, Dublin, Ireland|
|Principal Investigator:||George B Hanna, PhD FRCS||St. Mary's Hospital, London, United Kingdom|
|Principal Investigator:||Magnus Nilsson, MD FRCS||Karolinska Institutet, Stockholm, Sweden|