Cologne Esophageal Response Prediction Study (CERP-Study) (CERP)
RATIONALE: The prognosis of patients with advanced esophageal cancer may be improved by preoperative chemoradiation. But only those patients have a benefit from this additional therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to identify before starting the therapy those patients who response.
PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients with cancer of the esophagus.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Prospective Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of ERCC1 in Response to Treatment With Neoadjuvant Radiochemotherapy in Patients With Esophageal Cancer|
- histopathologic response to chemoradiation [ Time Frame: 1 month postoperative ] [ Designated as safety issue: No ]
Patients with cT3 esophageal cancer received RTx/CTx according a standardized protocol. 6 weeks after this neoadjuvant therapy a tranthoracic esophagectomy with two-field lymphadenectomy will be performed.
The histopathologic response is measured using the surgical specimen.
- prognosis [ Time Frame: 2 years after surgical resection ] [ Designated as safety issue: No ]All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Genetic: ERCC1 pathways analysis
The gene polymorphism of ERCC1 rs11615 and the pathways of ERRC1 will be analyzed in endoscopic tumor biopsies as well as in normal tissues prior to therapy. The results will be compared with histopathologic response after neoadjuvant therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953511
|Contact: Elfriede Bollschweiler, MD||0049 221 478 6273||Elfriede.Bollschweiler@uk-koeln.de|
|Department of General, Visceral and Cancer Surgery, University of Cologne||Recruiting|
|Cologne, NRW, Germany, 50924|
|Principal Investigator: Ralf Metzger, MD|
|Principal Investigator:||Arnulf H. Hölscher, MD||Department of General, Visceral and Cancer Surgery, University of Cologne|