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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- STATUS
- Recruiting
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- sponsor
- Centre Hospitalier Universitaire Dijon
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 |
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| Treatment | Systematic surgery, Surveillance and rescue surgery in cases of resectable loco-regional recurrence |
| Clinical Study Identifier | NCT02551458 |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Last Modified on | 22 January 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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