NCT02551458

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

SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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)).

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Systematic surgery
OTHER	Surveillance and rescue surgery in cases of resectable loco-regional recurrence

Timeline

• Start date: 2016-03-14
• Primary completion: 2023-03-15
• First posted: 2015-09-16
• Last updated: 2024-03-07

Locations

18 sites across 1 country: France