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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
Sponsor:
Collaborators:
St Mary's Hospital, Paddington, London
Karolinska Institutet
Information provided by (Responsible Party):
Dr Jessie A Elliott, St. James's Hospital, Ireland

Brief Summary:

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

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Other Names:
  • Screening for recurrence
  • Oncologic surveillance
  • Imaging follow-up




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion criteria

  1. Age 18 years and above
  2. Underwent surgery with curative intent for cTxNxM0 esophageal or esophagogastric junction (Siewert type I, II and III) cancer
  3. Salvage surgery after failure of primary endoscopic or oncologic treatment will be included

Exclusion criteria

  1. Endoscopic therapy or definitive oncological treatment as sole therapy for esophageal cancer
  2. Missing follow-up data

Information from the National Library of Medicine

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


Locations
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Ireland
Department of Surgery, St. James's Hospital
Dublin, Ireland, D4
Sweden
Karolinska Institutet
Stockholm, Sweden
United Kingdom
Department of Surgery and Cancer, 10th Floor, QEQM building, St. Mary's Hospital
London, United Kingdom, W21NY
Sponsors and Collaborators
St. James's Hospital, Ireland
St Mary's Hospital, Paddington, London
Karolinska Institutet
Investigators
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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

Additional Information:
Publications:

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Responsible Party: Dr Jessie A Elliott, Surgical Research Fellow, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT03461341    
Other Study ID Numbers: SJHDOS201801
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases