Cologne Esophageal Response Prediction Study (CERP-Study)

NCT00953511 | Completed DMC

• 1 other identifier: UK-09-118
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

esophagus; chemoradiation; excision repair cross-complementing gene; polymorphism; response prediction

Outcome Measures

Primary Outcomes (1)

• histopathologic response to chemoradiation

  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.

  1 month postoperative

Secondary Outcomes (1)

• prognosis

  2 years after surgical resection

Study Arms (1)

genetic

OTHER

Genetic: ERCC1 pathways analysis

Interventions

ERCC1 pathways analysis GENETIC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• missing informed consent
• prior radiation or chemotherapy
• second malignancy

Sponsors & Collaborators

• Elfriede Bollschweiler: lead

Study Sites (1)

Department of General, Visceral and Cancer Surgery, University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (5)

• Warnecke-Eberz U, Vallbohmer D, Alakus H, Kutting F, Lurje G, Bollschweiler E, Wienand-Dorweiler A, Drebber U, Holscher 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. doi: 10.1007/s11605-009-0881-z. Epub 2009 May 7.

  PMID: 19421825 BACKGROUND

• Brabender J, Vallbohmer D, Grimminger P, Hoffmann AC, Ling F, Lurje G, Bollschweiler E, Schneider PM, Holscher 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. doi: 10.1007/s11605-008-0668-7. Epub 2008 Sep 3.

  PMID: 18769985 BACKGROUND

• Bollschweiler E, Metzger R, Drebber U, Baldus S, Vallbohmer D, Kocher M, Holscher AH. Histological type of esophageal cancer might affect response to neo-adjuvant radiochemotherapy and subsequent prognosis. Ann Oncol. 2009 Feb;20(2):231-8. doi: 10.1093/annonc/mdn622. Epub 2008 Oct 3.

  PMID: 18836090 BACKGROUND

• 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. doi: 10.1097/01.sla.0000186170.38348.7b.

  PMID: 16244542 BACKGROUND

• Bollschweiler E, Holscher AH, Herbold T, Metzger R, Alakus H, Schmidt H, Drebber U, Warnecke-Eberz U. Molecular Markers for the Prediction of Minor Response to Neoadjuvant Chemoradiation in Esophageal Cancer: Results of the Prospective Cologne Esophageal Response Prediction (CERP) Study. Ann Surg. 2016 Nov;264(5):839-846. doi: 10.1097/SLA.0000000000001911.

  PMID: 27741011 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Arnulf H. Hölscher, MD

  Department of General, Visceral and Cancer Surgery, University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgical Research

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)