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Completed

NCT Number: NCT00953511

Cologne Esophageal Response Prediction Study (CERP-Study)

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cologne, North Rhine-Westphalia, 50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Elfriede Bollschweiler

Other

Registry information

Official study 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

Acronym: CERP

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2009
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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