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

History of Changes

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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

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

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:

Warnecke-Eberz U, Vallböhmer D, Alakus H, Kütting F, Lurje G, Bollschweiler E, Wienand-Dorweiler A, Drebber U, Hölscher AH, Metzger R. ERCC1 and XRCC1 gene polymorphisms predict response to neoadjuvant radiochemotherapy in esophageal cancer. J Gastrointest Surg. 2009 Aug;13(8):1411-21. Epub 2009 May 7.

Brabender J, Vallböhmer D, Grimminger P, Hoffmann AC, Ling F, Lurje G, Bollschweiler E, Schneider PM, Hölscher AH, Metzger R. ERCC1 RNA expression in peripheral blood predicts minor histopathological response to neoadjuvant radio-chemotherapy in patients with locally advanced cancer of the esophagus. J Gastrointest Surg. 2008 Nov;12(11):1815-21. Epub 2008 Sep 3.

Bollschweiler E, Metzger R, Drebber U, Baldus S, Vallböhmer D, Kocher M, Hölscher AH. Histological type of esophageal cancer might affect response to neo-adjuvant radiochemotherapy and subsequent prognosis. Ann Oncol. 2009 Feb;20(2):231-8. Epub 2008 Oct 3.

Schneider PM, Baldus SE, Metzger R, Kocher M, Bongartz R, Bollschweiler E, Schaefer H, Thiele J, Dienes HP, Mueller RP, Hoelscher AH. Histomorphologic tumor regression and lymph node metastases determine prognosis following neoadjuvant radiochemotherapy for esophageal cancer: implications for response classification. Ann Surg. 2005 Nov;242(5):684-92.

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 Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013

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