Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT00843635
Eligibility Criteria:
INCLUSION CRITERIA:
* Patients with surgically resectable oral cavity SCC, all subsites, T1 - T4, N0 - N3
* Patients with surgically resectable oropharyngeal SCC, all subsites, T1 - T2, N0 - N1
* Patients with surgically resectable T4 oropharyngeal SCC, all subsites, N0 - N3
* Patients must be 18 years old or older
EXCLUSION CRITERIA:
* Patients with previous surgical resection, radiation, or chemotherapy will be excluded to rule out possible effects of local tissue changes secondary to previous treatment
* Patients with surgically unresectable disease at primary site or regional lymph nodes
* Patients with T1 - T2 SCC oropharynx, N2 - N3
* Patients with T3 SCC oropharynx , N0 - N3
* Any patient for whom non-surgical therapy is recommended as treatment of choice after multidisciplinary treatment evaluation
* Patients with an altered mental status or not capacitated for their medical decision making
* Patients with severe or unstable cardiac or cerebrovascular disease are excluded
* myocardial infarction within the last 90 days
* unstable angina or angina occurring during sexual intercourse
* New York Heart Association Class 2 or greater heart failure in the last 6 months
* uncontrolled arrhythmias
* hypotension (\<90/50 mm Hg), or uncontrolled hypertension (\>170/100 mm Hg)
* stroke within the last 6 months
* Left ventricle outflow obstruction.
* Pregnant and nursing mothers will not be enrolled given unknown effects to offspring
* Concurrent nitrate, alpha-blocker, or cytochrome P-450 inhibitor use
* Renal Insufficiency defined as creatinine clearance less than 51.
* Creatinine clearance will be determined by the following Cockcroft-Gault Equation: (140-age) \* (Wt in kg) \* (0.85 if female) / (72 \* Cr)
* Patients with hepatic insufficiency.
* Patients currently taking a Phosphodiesterase (PDE) inhibitors for erectile dysfunction
* Patients who are immunocompromised, for reasons not directly related to patients malignancy
* Patients with significant alcohol or drug abuse
* Patients with unilateral blindness, hereditary retinal disorders, or increased risk of blindness
* Patients with unilateral deafness, history of hearing loss, hearing aid dependence, or clinically evident hearing loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00843635
Study Brief:
Protocol Section:
NCT00843635