CClinicalTrials.gg
CompletedNCT00620139Updated Oct 24, 2013

Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma

An observational study in Head and Neck Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-24.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study summary

This pilot study seeks to evaluate the feasibility of measuring the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes to evaluate the extent to which CRT induces the differential expression of components along two critical, and potentially interdependent, molecular pathways: the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways.

02

Conditions studied

  • Head and Neck Squamous Cell Carcinoma

Keywords

  • head and neck squamous cell carcinoma
  • chemoradiotherapy
  • molecular effects
  • 05-016
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 17 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

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

04

Who can participate

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

Study population

MSKCC clinics

Inclusion criteria

  • Untreated HNSCC (> Stage I) amenable to transoral biopsy.
  • Scheduled for concurrent CRT (Cisplatin or Carboplatin/5-FU based) as definitive primary treatment
  • Older than 18 years of age.
  • Understand and sign informed consent.

Exclusion criteria

Exclusion Criteria:

  • Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
  • Breast-feeding, pregnancy or of childbearing potential (including those women who are less than two years post menopausal) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
  • History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease, rheumatoid arthritis or pancreatitis).
  • Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
  • NSAID (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.
  • Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • A

    Some patients presenting with suspicious lesions of the oropharynx or oral cavity will need to undergo transoral biopsy in the clinic to confirm the diagnosis of carcinoma. Of those patients who choose to participate in the study, an extra piece of tumor will be harvested for investigational purposes related to this trial.

    Biological: the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,

Interventions

  • Biologicalthe arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,

    patient will undergo transoral pretreatment biopsy of the tumor. A comparable second tumor biopsy will be performed in the office after exactly 5 days of concurrent CRT (5 daily fractions of 180-200 cGy radiotherapy and a single cycle of Cisplatin or Carboplatin/5-FU based chemotherapy).Blood plasma and single-void urine specimens will be collected contemporaneously,before and after 5 days of concurrent CRT.

06

What researchers measure

Primary outcomes

  1. To evaluate the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic molecular targets along the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways in HNSCC.

    Time frame: Conclusion of the study

07

Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00620139
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Feb 21, 2008
Start date
Mar 2005
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Oct 24, 2013

Study contacts

Nancy Lee, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion