Viewing Study NCT01192750



Ignite Creation Date: 2024-05-05 @ 10:50 PM
Last Modification Date: 2024-10-26 @ 10:24 AM
Study NCT ID: NCT01192750
Status: COMPLETED
Last Update Posted: 2017-05-17
First Post: 2010-08-31

Brief Title: Biomakers in Tissue Samples From Patients With Recurrent andor Metastatic Squamous Cell Cancer of the Head and Neck Previously Treated With Cisplatin With or Without Cetuximab
Sponsor: ECOG-ACRIN Cancer Research Group
Organization: Eastern Cooperative Oncology Group

Study Overview

Official Title: Retrospective Analysis of ERCC1 Expression in Patients With RecurrentMetastatic Squamous Cell Carcinoma of the Head and Neck SCCHN Who Received Cisplatin or Cisplatin and Cetuximab
Status: COMPLETED
Status Verified Date: 2017-05
Last Known Status: None
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: RATIONALE Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

PURPOSE This research study is studying biomarkers in tissue samples from patients with recurrent andor metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab
Detailed Description: OBJECTIVES

To investigate the association between ERCC1 expression and clinical outcomes response rate progression-free survival and overall survival in patients with recurrent andor metastatic squamous cell carcinoma of the head and neck who received cisplatin with versus without cetuximab on clinical trial ECOG-E5397

OUTLINE Archived tumor tissue samples are analyzed for ERCC1 expression by IHC ERCC1 levels low or high are assessed by an H-score and AQUA a quantitative IHC analysis Each patients ERCC1 level result is then compared with the patients clinical outcome

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
ECOG-E5397T1 None None None