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

  • STATUS
    Recruiting
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 21 January 2021

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)).

Details
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 on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II) or Adenocarcinoma of the Thoracic Oesophagus or or Stage cT2 N1-3 M0 or cT3-T4a N0 o...?
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)
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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.

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