CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
ERCC1 pathways analysisgenetic
Likely dose
Not stated in record
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Search/NCT00953511
NCT00953511N/ACompleted

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

Elfriede Bollschweiler·interventional·Posted Aug 6, 2009·Updated Oct 21, 2016

In Brief

A clinical study evaluating ERCC1 pathways analysis for Esophageal Cancer. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartAug 1, 2009
Primary CompletionApr 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.9 years ago

Interventions

ERCC1 pathways analysisgenetic

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.