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CompletedNCT00953511CERPUpdated Oct 21, 2016

Cologne Esophageal Response Prediction Study (CERP-Study)

An interventional study of ERCC1 pathways analysis in Esophageal Cancer, sponsored by Elfriede Bollschweiler. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-21.

Sponsored by Elfriede Bollschweiler · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Esophageal Cancer

Keywords

  • esophagus
  • chemoradiation
  • excision repair cross-complementing gene
  • polymorphism
  • response prediction
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 80 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

This is the only study on the registry with Elfriede Bollschweiler as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Other
    genetic

    Genetic: ERCC1 pathways analysis

Interventions

  • GeneticERCC1 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.

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What researchers measure

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.

    Time frame: 1 month postoperative

Secondary outcomes

  1. prognosis

    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

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Study locations

1 site
  • Department of General, Visceral and Cancer Surgery, University of Cologne
    Cologne, NRW 50924, Germany
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References and documents

Publications

  • 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. PubMed 19421825 ↗
  • 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. PubMed 18769985 ↗
  • 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. PubMed 18836090 ↗
  • 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. PubMed 16244542 ↗
  • 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. PubMed 27741011 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00953511
Lead sponsor
Elfriede Bollschweiler
Responsible party
Elfriede Bollschweiler (Professor of Surgical Research, University of Cologne) — Sponsor-investigator
First posted
Aug 6, 2009
Start date
Aug 2009
Primary completion
Apr 2015
Completion
Aug 2015
Last update
Oct 21, 2016

Study contacts

Arnulf H. Hölscher, MD
principal investigator · Department of General, Visceral and Cancer Surgery, University of Cologne

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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