Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
head and neck squamous cell carcinoma, chemoradiotherapy, molecular effects, 05-016
Brief 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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Conclusion of the study |
Countries
United States
Outcome results
None listed