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

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Biological: the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,

• Registration Number: NCT00620139
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-21
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States