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Trial record 1 of 1 for:    ESOSTRATE
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Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy (Esostrate)

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ClinicalTrials.gov Identifier: NCT02551458
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE August 20, 2015
First Posted Date  ICMJE September 16, 2015
Last Update Posted Date September 16, 2015
Study Start Date  ICMJE Not Provided
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September¬†14,¬†2015)
  • Proportion of surviving patients [ Time Frame: 1 year after randomisation ]
  • Disease-free survival [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
Official Title  ICMJE SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
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)).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Not Provided
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Other: Systematic surgery
  • Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Study Arms  ICMJE
  • Experimental: Arm A: Systematic surgery
    Intervention: Other: Systematic surgery
  • Experimental: Arm B: Surveillance and rescue surgery in cases of resectable
    Intervention: Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE
Contact: Laurent BEDENNE 3 80 38 13 14 ext +33 laurent.bedenne@u-bourgogne.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02551458
Other Study ID Numbers  ICMJE Bedenne PHRC N 2013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP