Cologne Esophageal Response Prediction Study (CERP-Study) (CERP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Elfriede Bollschweiler, University of Cologne
ClinicalTrials.gov Identifier:
NCT00953511
First received: August 3, 2009
Last updated: December 1, 2014
Last verified: December 2014

August 3, 2009
December 1, 2014
August 2009
December 2014   (final data collection date for primary outcome measure)
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.

histopathologic response to chemoradiation [ Time Frame: 1 month postoperative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00953511 on ClinicalTrials.gov Archive Site
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.
prognosis [ Time Frame: 2 years after surgical resection ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cologne Esophageal Response Prediction Study (CERP-Study)
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Esophageal Cancer
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.
genetic
Intervention: Genetic: ERCC1 pathways analysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • informed consent
  • newly diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus or cardia

Exclusion Criteria:

  • missing informed consent
  • prior radiation or chemotherapy
  • second malignancy
Both
18 Years and older   (Adult, Senior)
No
Contact: Elfriede Bollschweiler, MD 0049 221 478 6273 Elfriede.Bollschweiler@uk-koeln.de
Germany
 
NCT00953511
UK-09-118
Yes
Not Provided
Not Provided
Elfriede Bollschweiler, University of Cologne
Elfriede Bollschweiler
Not Provided
Principal Investigator: Arnulf H. Hölscher, MD Department of General, Visceral and Cancer Surgery, University of Cologne
University of Cologne
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP