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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|ClinicalTrials.gov Identifier: NCT02551458|
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
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)).
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Systematic surgery Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY|
|Estimated Primary Completion Date :||March 2023|
|Experimental: Arm A: Systematic surgery||
Other: Systematic surgery
|Experimental: Arm B: Surveillance and rescue surgery in cases of resectable||
Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence
- Proportion of surviving patients [ Time Frame: 1 year after randomisation ]
- Disease-free survival [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551458
|Contact: Laurent BEDENNE||3 80 38 13 14 ext +firstname.lastname@example.org|