Head and Neck Cancer Clinical Trial
Official title:
Comparison of FLT and FDG PET in the Evaluation of Response to Cetuximab, Cisplatin and Radiation Therapy in Advanced Head and Neck Malignancies or Response to Standard Chemo-radiotherapy in Esophageal Malignancies
Verified date | March 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) and
fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to
treatment and help plan the best treatment.
PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate
response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of
the oropharynx, larynx, or hypopharynx.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 25, 2017 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx - Advanced disease - Requires chemoradiotherapy PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Life expectancy = 16 weeks - Weight loss = 10% within the past 3 months - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - ANC = 1,500/mm³ - Platelet count = 100,000/mm³ - Total bilirubin = 1.5 times upper limit of normal (ULN) - AST = 3 times ULN - Hemoglobin = 8 g/dL - Creatinine clearance = 40 mL/min - No peripheral neuropathy = grade 2 - No NYHA class III-IV heart disease - No uncontrolled infection - No poorly controlled diabetes that would limit the ability to obtain reliable fludeoxyglucose F 18 PET scan results - No other severe underlying disease that, in the judgment of the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: - More than 2 weeks since prior major surgery and recovered - No prior radiotherapy to the planned treatment field - No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change in the standard uptake value levels calculated for the identified volumes of interest for FLT and FDG PET scans from baseline to after 2 weeks of cetuximab therapy and from baseline to after 20-30 Gy of radiotherapy | |||
Secondary | Quantified change values (after cetuximab therapy and after 20-30 Gy of radiotherapy) for the FLT and FDG PET scan-based topographic profiles created using the ImQuant software package |
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