Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00620139
First received: January 25, 2008
Last updated: January 7, 2013
Last verified: January 2013
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma |
Resource links provided by NLM:
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
Urine Blood Tissue
| Enrollment: | 17 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (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.
|
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:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00620139 History of Changes |
| Other Study ID Numbers: | 05-016 |
| Study First Received: | January 25, 2008 |
| Last Updated: | January 7, 2013 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013