Cologne Esophageal Response Prediction Study (CERP-Study)

Elfriede Bollschweiler

Status: Completed

Conditions: Esophageal Cancer

Treatments: Genetic: ERCC1 pathways analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00953511

UK-09-118

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

genetic

Other group

Treatment:

Genetic: ERCC1 pathways analysis