search
Back to results

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

Primary Purpose

Epidermoid Carcinoma or, Adenocarcinoma of the Thoracic Oesophagus or, Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II)

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Systematic surgery
Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Epidermoid Carcinoma or

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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)

Sites / Locations

  • CHU AmiensRecruiting
  • Centre d'oncologie et de radiothérapie du Pays BasqueRecruiting
  • CH de la Côte BasqueRecruiting
  • Boulogne Sur MerRecruiting
  • Infirmerie protestante de LyonRecruiting
  • Hôpitaux civils de ColmarRecruiting
  • CHU de DIJONRecruiting
  • Hôpital Michallon (GRENOBLE)Recruiting
  • Centre Oscar LambretRecruiting
  • Hôpital Claude HuriezRecruiting
  • Clinique ChenieuxRecruiting
  • CHU de LimogesRecruiting
  • CH Saint Joseph Saint LucRecruiting
  • Hôpital privé Jean MermozRecruiting
  • Institut Mutualiste MONTSOURISRecruiting
  • Centre Hospitalier Annecy GenevoisRecruiting
  • CHP Saint GrégoireRecruiting
  • Institut Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Systematic surgery

Arm B: Surveillance and rescue surgery in cases of resectable

Arm Description

Outcomes

Primary Outcome Measures

Proportion of surviving patients
Disease-free survival

Secondary Outcome Measures

Full Information

First Posted
August 20, 2015
Last Updated
September 14, 2015
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT02551458
Brief Title
Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
Acronym
Esostrate
Official Title
SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief Summary
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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermoid Carcinoma or, Adenocarcinoma of the Thoracic Oesophagus or, Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II), Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0

7. Study Design

Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Arm Title
Arm A: Systematic surgery
Arm Type
Experimental
Arm Title
Arm B: Surveillance and rescue surgery in cases of resectable
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Systematic surgery
Intervention Type
Other
Intervention Name(s)
Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Primary Outcome Measure Information:
Title
Proportion of surviving patients
Time Frame
1 year after randomisation
Title
Disease-free survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent BEDENNE
Phone
3 80 38 13 14
Ext
+33
Email
laurent.bedenne@u-bourgogne.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBAUD
Facility Name
Centre d'oncologie et de radiothérapie du Pays Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane REMY
Facility Name
CH de la Côte Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck AUDEMAR
Facility Name
Boulogne Sur Mer
City
Boulogne-sur-mer
ZIP/Postal Code
62200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BOURGEOIS
Facility Name
Infirmerie protestante de Lyon
City
Caluire et Cuire
ZIP/Postal Code
69300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes HATWIG
Facility Name
Hôpitaux civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles BREYSACHER
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BEDENNE
Facility Name
Hôpital Michallon (GRENOBLE)
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques BALOSSO
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine ADENIS
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine ADENIS
Facility Name
Clinique Chenieux
City
Limoges
ZIP/Postal Code
87039
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier ZASADNY
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine LAVAU-DENES
Facility Name
CH Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis PERE VERGE
Facility Name
Hôpital privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard LLEDO
Facility Name
Institut Mutualiste MONTSOURIS
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe LOUVET
Facility Name
Centre Hospitalier Annecy Genevois
City
Pringy
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu BACONNIER
Facility Name
CHP Saint Grégoire
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent MUGLIANICO
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric DEUTSCH

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs