Viewing Study NCT01444547



Ignite Creation Date: 2024-05-05 @ 11:54 PM
Last Modification Date: 2024-10-26 @ 10:41 AM
Study NCT ID: NCT01444547
Status: UNKNOWN
Last Update Posted: 2014-05-06
First Post: 2011-09-28

Brief Title: A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
Sponsor: Chinese Academy of Medical Sciences
Organization: ChineseAMS

Study Overview

Official Title: A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin
Status: UNKNOWN
Status Verified Date: 2014-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
Detailed Description: Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer 92 Patients will be enrolled in this local trial The primary objective of this study is to determine the response rate of the treatmentSchedule for this study is as follows paclitaxel 150 mgm2 will be administered as an intravenous infusion over 3 hour on Days 1 followed by cisplatin 50 mgm2 on Days 2 This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Z111107058811023 REGISTRY CH-GI-021 None