search
Back to results

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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ERCC1 pathways analysis
Sponsored by
Elfriede Bollschweiler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring esophagus, chemoradiation, excision repair cross-complementing gene, polymorphism, response prediction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

genetic

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

prognosis
All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.

Full Information

First Posted
August 3, 2009
Last Updated
October 19, 2016
Sponsor
Elfriede Bollschweiler
search

1. Study Identification

Unique Protocol Identification Number
NCT00953511
Brief Title
Cologne Esophageal Response Prediction Study (CERP-Study)
Acronym
CERP
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elfriede Bollschweiler

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophagus, chemoradiation, excision repair cross-complementing gene, polymorphism, response prediction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
genetic
Arm Type
Other
Intervention Type
Genetic
Intervention Name(s)
ERCC1 pathways analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
histopathologic response to chemoradiation
Description
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.
Time Frame
1 month postoperative
Secondary Outcome Measure Information:
Title
prognosis
Description
All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.
Time Frame
2 years after surgical resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnulf H. Hölscher, MD
Organizational Affiliation
Department of General, Visceral and Cancer Surgery, University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General, Visceral and Cancer Surgery, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19421825
Citation
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.
Results Reference
background
PubMed Identifier
18769985
Citation
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.
Results Reference
background
PubMed Identifier
18836090
Citation
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.
Results Reference
background
PubMed Identifier
16244542
Citation
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.
Results Reference
background
PubMed Identifier
27741011
Citation
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.
Results Reference
result

Learn more about this trial

Cologne Esophageal Response Prediction Study (CERP-Study)

We'll reach out to this number within 24 hrs