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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953511
First Posted: August 6, 2009
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elfriede Bollschweiler, University of Cologne
  Purpose

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.


Condition Intervention
Esophageal Cancer Genetic: ERCC1 pathways analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Elfriede Bollschweiler, University of Cologne:

Primary Outcome Measures:
  • histopathologic response to chemoradiation [ Time Frame: 1 month postoperative ]

    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.



Secondary Outcome Measures:
  • prognosis [ Time Frame: 2 years after surgical resection ]
    All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.


Enrollment: 80
Study Start Date: August 2009
Study Completion Date: August 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
genetic 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00953511


Locations
Germany
Department of General, Visceral and Cancer Surgery, University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
Elfriede Bollschweiler
Investigators
Principal Investigator: Arnulf H. Hölscher, MD Department of General, Visceral and Cancer Surgery, University of Cologne
  More Information

Publications:

Responsible Party: Elfriede Bollschweiler, Professor of Surgical Research, University of Cologne
ClinicalTrials.gov Identifier: NCT00953511     History of Changes
Other Study ID Numbers: UK-09-118
First Submitted: August 3, 2009
First Posted: August 6, 2009
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elfriede Bollschweiler, University of Cologne:
esophagus
chemoradiation
excision repair cross-complementing gene
polymorphism
response prediction

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases