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CompletedNCT01194635Updated May 17, 2017

Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy

An observational study in Head and Neck Cancer, sponsored by ECOG-ACRIN Cancer Research Group. Completed. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by ECOG-ACRIN Cancer Research Group · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
69
Ages
18 Years to 120 Years
Sex
All
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Study summary

RATIONALE: Studying samples of blood and tumor 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. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.

Read the detailed description

OBJECTIVES:

Primary

  • To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
  • To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).

OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.

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Conditions studied

  • Head and Neck Cancer

Keywords

  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 69 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Samples from patients enrolled on E3303 from whom samples were submitted for research

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of squamous cell carcinoma of the head and neck

    • Stage IV disease
    • Unresectable disease
  • Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303
  • Archived blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
69 participants (actual)

Interventions

  • Geneticfluorescence in situ hybridization
  • Geneticgene expression analysis
  • Geneticpolymerase chain reaction
  • Geneticprotein analysis
  • Geneticprotein expression analysis
  • Otherenzyme-linked immunosorbent assay
  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Correlation of biomarkers and clinical outcome

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01194635
Lead sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 3, 2010
Start date
Aug 5, 2010
Primary completion
Sep 5, 2010
Completion
Sep 5, 2010
Last update
May 17, 2017

Study contacts

Jennifer R. Grandis, MD
principal investigator · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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