Biomakers in Tissue Samples From Patients With Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck Previously Treated With Cisplatin With or Without Cetuximab

May 16, 2017 updated by: ECOG-ACRIN Cancer Research Group

Retrospective Analysis of ERCC1 Expression in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Received Cisplatin or Cisplatin and Cetuximab

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 and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 and/or 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 patient's ERCC1 level result is then compared with the patient's clinical outcome.

Study Type

Observational

Enrollment (Actual)

79

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples from patients enrolled on E5397 from whom samples were submitted for research

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of squamous cell carcinoma of the head and neck

    • Recurrent and/or metastatic disease
  • Received cisplatin with or without cetuximab on clinical trial ECOG-E5397
  • Slides and blocks of tumor specimens available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association between ERCC1 expression (low or high) with clinical outcomes
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 5, 2010

Primary Completion (ACTUAL)

October 5, 2010

Study Completion (ACTUAL)

October 5, 2010

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (ESTIMATE)

September 1, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000683281
  • ECOG-E5397T1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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