European iNvestigation of SUrveillance After Resection for Esophageal Cancer

NCT03461341 | Completed

• 1 other identifier: SJHDOS201801
• Study Type: observational
• Target: 3,000
• Locations: 3 countries
• Sites: 3

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.

Conditions

Esophageal Cancer; Metastatic Cancer; Recurrent Esophageal Cancer; Chemoradiation; Chemotherapy; Radiation; Surgery

Outcome Measures

Primary Outcomes (3)

• Overall survival (months)

  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.

  Minimum 3 year follow-up for all patients

• Disease-specific survival (months)

  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.

  Minimum 3 year follow-up for all patients

• Utilisation of routine surveillance imaging across European Centers

  The proportion of European Centers utilising routine postperative oncologic surveillance imaging will be determined by email survey.

  2009 - 2015

Secondary Outcomes (3)

• Isolated solid organ metastasis (ISOM) at first recurrence

  Minimum 3 year follow-up for all patients

• Isolated local recurrence (ILR) at first recurrence

  Minimum 3 year follow-up for all patients

• Health-related quality of life (HR-QL) as assessed by EORTC QLQ-C30 questionnaire

  At one year postoperatively

Study Arms (1)

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

Interventions

High intensity postoperative oncologic surveillance OTHER

High intensity surveillance protocol using routine cross-sectional imaging (computed tomography or positron emission tomography with computed tomography).

Also known as: Screening for recurrence, Oncologic surveillance, Imaging follow-up

Patients post curative intent surgery for esophageal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead
• St Mary's Hospital, Paddington, London: collaborator
• Karolinska Institutet: collaborator

Study Sites (3)

Department of Surgery, St. James's Hospital

Dublin, D4, Ireland

Location

Karolinska Institutet

Stockholm, Sweden

Location

Department of Surgery and Cancer, 10th Floor, QEQM building, St. Mary's Hospital

London, W21NY, United Kingdom

Location

Related Publications (7)

• Antonowicz SS, Lorenzi B, Parker M, Tang CB, Harvey M, Kadirkamanathan SS. Annual computed tomography scans do not improve outcomes following esophagectomy for cancer: a 10-year UK experience. Dis Esophagus. 2015 May-Jun;28(4):365-70. doi: 10.1111/dote.12209. Epub 2014 Mar 20.

  PMID: 24649807 BACKGROUND

• Messager M, de Steur W, Boelens PG, Jensen LS, Mariette C, Reynolds JV, Osorio J, Pera M, Johansson J, Kolodziejczyk P, Roviello F, De Manzoni G, Monig SP, Allum WH; EURECCA Upper GI group (European Registration of Cancer Care). Description and analysis of clinical pathways for oesophago-gastric adenocarcinoma, in 10 European countries (the EURECCA upper gastro intestinal group - European Registration of Cancer Care). Eur J Surg Oncol. 2016 Sep;42(9):1432-47. doi: 10.1016/j.ejso.2016.01.001. Epub 2016 Feb 6.

  PMID: 26898839 BACKGROUND

• Peixoto RD, Lim HJ, Kim H, Abdullah A, Cheung WY. Patterns of surveillance following curative intent therapy for gastroesophageal cancer. J Gastrointest Cancer. 2014 Sep;45(3):325-33. doi: 10.1007/s12029-014-9601-3.

  PMID: 24756830 BACKGROUND

• Depypere L, Lerut T, Moons J, Coosemans W, Decker G, Van Veer H, De Leyn P, Nafteux P. Isolated local recurrence or solitary solid organ metastasis after esophagectomy for cancer is not the end of the road. Dis Esophagus. 2017 Jan 1;30(1):1-8. doi: 10.1111/dote.12508.

  PMID: 27704661 BACKGROUND

• Sisic L, Strowitzki MJ, Blank S, Nienhueser H, Dorr S, Haag GM, Jager D, Ott K, Buchler MW, Ulrich A, Schmidt T. Postoperative follow-up programs improve survival in curatively resected gastric and junctional cancer patients: a propensity score matched analysis. Gastric Cancer. 2018 May;21(3):552-568. doi: 10.1007/s10120-017-0751-4. Epub 2017 Jul 24.

  PMID: 28741059 BACKGROUND

• Abate E, DeMeester SR, Zehetner J, Oezcelik A, Ayazi S, Costales J, Banki F, Lipham JC, Hagen JA, DeMeester TR. Recurrence after esophagectomy for adenocarcinoma: defining optimal follow-up intervals and testing. J Am Coll Surg. 2010 Apr;210(4):428-35. doi: 10.1016/j.jamcollsurg.2010.01.006.

  PMID: 20347734 BACKGROUND

• Elliott JA, Markar SR, Klevebro F, Johar A, Goense L, Lagergren P, Zaninotto G, van Hillegersberg R, van Berge Henegouwen MI, Nilsson M, Hanna GB, Reynolds JV; ENSURE Study Group. An International Multicenter Study Exploring Whether Surveillance After Esophageal Cancer Surgery Impacts Oncological and Quality of Life Outcomes (ENSURE). Ann Surg. 2023 May 1;277(5):e1035-e1044. doi: 10.1097/SLA.0000000000005378. Epub 2022 Jan 27.

  PMID: 35129466 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasm Metastasis

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Research Fellow

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 12, 2018
• Study Start: June 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

IE (1); SE (1); GB (1)