Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00620139

Purpose

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.

Condition	Intervention	Phase
Head and Neck Squamous Cell Carcinoma	Biological: the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,	Phase 0

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: Conclusion of the study ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Urine Blood Tissue

Enrollment:	17
Study Start Date:	March 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A 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.	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.

Groups/Cohorts

Assigned Interventions

A

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC clinics

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620139

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Nancy Lee, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Nancy Lee, M.D. )
Study ID Numbers:	05-016
Study First Received:	January 25, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00620139 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

head and neck squamous cell carcinoma
chemoradiotherapy
molecular effects
05-016

Study placed in the following topic categories:

Cisplatin
Fluorouracil
Epidermoid Carcinoma
Carboplatin
Neoplasms, Squamous Cell

Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009