Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy (Esostrate)

March 5, 2024 updated by: Centre Hospitalier Universitaire Dijon

SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY

Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.

The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.

Evaluation of the response 5 to 6 weeks after the RCT.

Step 2: Randomisation in patients with a complete clinical response:

Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence

Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Bayonne, France, 64109
        • CH de la Côte Basque
      • Bayonne, France, 64100
        • Centre d'oncologie et de radiothérapie du Pays Basque
      • Boulogne-sur-mer, France, 62200
        • Boulogne Sur Mer
      • Caluire et Cuire, France, 69300
        • Infirmerie Protestante de Lyon
      • Colmar, France, 68024
        • Hopitaux Civils de Colmar
      • Dijon, France, 21079
        • CHU de Dijon
      • La Tronche, France, 38700
        • Hôpital Michallon (GRENOBLE)
      • Lille, France, 59000
        • Centre OSCAR LAMBRET
      • Lille, France, 59000
        • Hopital Claude Huriez
      • Limoges, France, 87042
        • CHU de Limoges
      • Limoges, France, 87039
        • Clinique Chenieux
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Lyon, France, 69007
        • Ch Saint Joseph Saint Luc
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Pringy, France, 74374
        • Centre Hospitalier Annecy Genevois
      • Saint Gregoire, France, 35760
        • CHP Saint Gregoire
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Epidermoid carcinoma (EC) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (Siewert type I or II) proven histologically
  • Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 after a full investigation
  • Patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting
  • Age ≥ 18 years < 75 years
  • Patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies.

Exclusion Criteria:

  • Cancer of the cervical oesophagus (15 to 19 cm from the dental arches)
  • Weight loss > 15% at the recruitment with no improvement after nutritional support
  • Serious comorbidity threatening survival in the short term
  • Contra-indication for radiochemotherapy
  • Other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers)
  • Absence of effective contraception in patients (men or women) able to procreate, pregnant or breast-feeding women
  • Impossibility to follow the trial
  • Legal disqualification (patients in custody or under guardianship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Systematic surgery
Other: Systematic surgery
Experimental: Arm B: Surveillance and rescue surgery in cases of resectable
Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: Up to 5 years
Up to 5 years
Proportion of surviving patients
Time Frame: 1 year after randomisation
1 year after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimated)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bedenne PHRC N 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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