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
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00953511
First received: August 3, 2009
Last updated: June 28, 2010
Last verified: August 2009
  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: 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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2010 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953511

Contacts
Contact: Elfriede Bollschweiler, MD 0049 221 478 6273 Elfriede.Bollschweiler@uk-koeln.de

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

Publications:
Responsible Party: University of Cologne, Department of General, Visceral and Cancer Surgery, University of Cologne (Head Dr. med. Arnulf H. Hölscher, Head of Department)
ClinicalTrials.gov Identifier: NCT00953511     History of Changes
Other Study ID Numbers: UK-09-118
Study First Received: August 3, 2009
Last Updated: June 28, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014