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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620139
• Other study ID #: 05-016
• Status: Completed
• Phase: Phase 0
• First received: January 25, 2008
• Last updated: October 23, 2013
• Start date: March 2005
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

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