Clinical Trials Logo

Clinical Trial 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)).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02551458
Study type Interventional
Source Centre Hospitalier Universitaire Dijon
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date March 14, 2016