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

Phase 0
18 Years
Open (Enrolling)
Head and Neck Squamous Cell Carcinoma

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Trial Information

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

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

Conclusion of the study

Safety Issue:


Principal Investigator

Nancy Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2005

Completion Date:

January 2014

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • head and neck squamous cell carcinoma
  • chemoradiotherapy
  • molecular effects
  • 05-016
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021