Cologne Esophageal Response Prediction Study (CERP-Study)

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Genetic: ERCC1 pathways analysis

• Registration Number: NCT00953511
• Lead Sponsor: Elfriede Bollschweiler

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
genetic	ERCC1 pathways analysis	-

Primary Outcome Measures

Name	Time	Method
histopathologic response to chemoradiation	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 Outcome Measures

Name	Time	Method
prognosis	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.

Trial Locations

Locations (1)

Department of General, Visceral and Cancer Surgery, University of Cologne; 🇩🇪 Cologne, NRW, Germany