Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005525

Trial Description

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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

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Trial Acronym

CERP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005525
  •   2014/02/11
  •   2009/08/03
  •   yes
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Secondary IDs

  •   NCT00953511  (ClinicalTrials.gov)
  •   UK-09-118  (University of Cologne)
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Health Condition or Problem studied

  •   Esophageal Cancer
  •   C15 -  Malignant neoplasm of oesophagus
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Interventions/Observational Groups

  •   Genetic: ERCC1 pathways analysis
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

- histopathologic response to chemoradiation; time frame: 1 month postoperative; 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.

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Secondary Outcome

- prognosis; time frame: 2 years after surgical resection; All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2009/08/31
  •   80
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- informed consent

- newly diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus or cardia

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Exclusion Criteria

- missing informed consent

- prior radiation or chemotherapy

- second malignancy

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Addresses

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    • University of Cologne
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    • Department of General, Visceral and Cancer Surgery, University of Cologne
    • Arnulf H. Hölscher, MD 
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    •   [---]*
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    • Elfriede Bollschweiler, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   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.; 19421825
  •   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.; 18769985
  •   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.; 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.; 16244542
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.