Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma
NCT ID: NCT00620139
Last Updated: 2013-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
17 participants
OBSERVATIONAL
2005-03-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
the 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.
Interventions
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the 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nancy Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Related Info
Other Identifiers
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05-016
Identifier Type: -
Identifier Source: org_study_id