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

  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 22 January 2022


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)).

Condition 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
Treatment Systematic surgery, Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Clinical Study IdentifierNCT02551458
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on22 January 2022


Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note