Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
carcinoma, cancer, head, neck, otolaryngology
Brief summary
To estimate the mean and standard deviation (SD) of the post-treatment decreases in the interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in patients with locally advanced squamous-cell carcinoma of the head and neck. The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid pressure within the tumors will be measured by assessing the trend and statistical significance of the difference in values for each condition obtained prior to and just after GRID exposure in each subject enrolled in the study. We expect that there may be a trend for increases in tumor oxygenation and decreases in interstitial fluid pressure which would indicate that more accurately timed additional chemotherapy and radiation therapy would improve overall patient outcomes.
Interventions
DRUG18F-MISO
A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 - 80 years of age * Karnofsky performance status greater than 70 or ECOG ≥ 2 * Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension. * History of adequate hepatic function (endoscopic or percutaneous drainage as needed): a. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN * Chemotherapy naive * History of adequate renal and bone marrow function: 1. Leukocytes ≥ 3000/uL 2. ANC ≥ 1500/uL 3. Platelets ≥ 100000/UI 4. Serum Creatinine ≤ 2.0 mg/dL
Exclusion criteria
* Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence * Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures * Subjects with known presence of central nervous system or brain metastases * Subjects with prior radiotherapy to the head and neck region * Subjects will be excluded if deemed unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment. | within 72 hours after GRID treatment |
Countries
United States
Outcome results
None listed