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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00002702
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven squamous cell carcinoma of the oral cavity or oropharynx
* Operable, primary, unilateral, stage T2-4, N0-3, M0 disease
* No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection)
* No tumor involvement of the following sites:
* Pterygopalatine fossa
* Carotid artery
* Maxillary sinus
* Facial skin
* Anterior floor of the mouth
* Base of the tongue infiltrating more than 1 cm
* Measurable or evaluable disease by physical exam and/or noninvasive imaging
PATIENT CHARACTERISTICS:
Age:
* 75 and under
Performance status:
* ECOG 0-2 OR
* Karnofsky 70-100%
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 4,000/mm3
* Platelet count at least 60,000/mm3
* Hematocrit at least 30%
Hepatic:
* Bilirubin normal
* Hepatitis B surface antigen negative
Renal:
* Creatinine normal
Cardiovascular:
* No congestive heart failure
* No uncontrolled hypertension
* No coronary artery disease
* No serious arrhythmia
* No evidence of prior myocardial infarction on ECG (stress test required if in doubt)
Other:
* HIV negative
* No autoimmune disease
* No contraindications to pressor agents
* No serious infection requiring antibiotics
* No other concurrent primary malignancy
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior or other concurrent immunotherapy
Chemotherapy:
* No prior or concurrent chemotherapy
Endocrine therapy:
* No prior or concurrent hormonal therapy
* No concurrent corticosteroids
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
* No prior major organ allografts
Other:
* No other prior therapy
* No other concurrent investigational drugs, agents, or devices
* No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00002702
Study Brief:
Protocol Section:
NCT00002702