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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

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

Biological

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2013
Study completion: 2013
First posted: Feb 21, 2008
Registry last updated: Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed