Cologne Esophageal Response Prediction Study (CERP-Study)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Cologne.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Cologne
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00953511
First received: August 3, 2009
Last updated: June 28, 2010
Last verified: August 2009
| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2009 | ||||
| Last Updated Date | June 28, 2010 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
histopathologic response to chemoradiation [ Time Frame: 1 months postoperative ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00953511 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
prognosis [ Time Frame: 2 years after surgical resection ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cologne Esophageal Response Prediction Study (CERP-Study) | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic |
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| Condition ICMJE | Esophageal Cancer | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | genetic
Intervention: Genetic: ERCC1 pathways analysis |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00953511 | ||||
| Other Study ID Numbers ICMJE | UK-09-118 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Cologne, Department of General, Visceral and Cancer Surgery, University of Cologne (Head Dr. med. Arnulf H. Hölscher, Head of Department) | ||||
| Study Sponsor ICMJE | University of Cologne | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Cologne | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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