Status:
COMPLETED
Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00620139
Start Date
March 1 2005
End Date
October 1 2013
Last Update
October 24 2013
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065