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)).
Study Type
INTERVENTIONAL
Enrollment
188
CHU Amiens
Amiens, France
Centre d'oncologie et de radiothérapie du Pays Basque
Bayonne, France
CH de la Côte Basque
Bayonne, France
Boulogne Sur Mer
Boulogne-sur-Mer, France
Infirmerie protestante de Lyon
Caluire-et-Cuire, France
Hôpitaux civils de Colmar
Colmar, France
CHU de DIJON
Dijon, France
Hôpital Michallon (GRENOBLE)
La Tronche, France
Centre Oscar Lambret
Lille, France
Hôpital Claude Huriez
Lille, France
...and 8 more locations
Proportion of surviving patients
Time frame: 1 year after randomisation
Disease-free survival
Time frame: Up to 5 years
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