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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00014118
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx
* No recurrent disease
* No evidence of distant metastasis
* Resectable disease, defined as follows:
* High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)
* No extension to root of tongue (for disease of the base of tongue)
* No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall)
* No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)
* No trismus (for disease of the tonsil, soft palate, or pharyngeal wall)
* No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis)
* For disease of the supraglottis, glottis, or subglottis:
* No base of the tongue invasion greater than 2 cm
* No tumor extension through cartilage to involve strap muscles of the neck
* No tumor fixation to prevertebral fascia
* No involvement of the carotid artery
* No fixed nodal disease with involvement of the deep neck
* Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx
* Measurable disease
* \- Lesions accurately measured in at least one dimension as \> 20 mm (2.0 cm) with conventional techniques or as \> 10 mm (1.0 cm) with spiral CT scan
* Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion
* No other concurrent head and neck neoplasms
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Not specified
Renal
* Creatinine less than 3.0 mg/dL
* Calcium normal
Cardiovascular
* No significant cardiac disease
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No myocardial infarction within the past year
* No serious cardiac arrhythmias requiring medication
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study completion
* No significant detectable infection
* No history of allergy to drugs containing Cremophor EL
* No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin
* No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
* No concurrent amifostine
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy above the clavicles
Surgery
* No prior surgery to the primary tumor except biopsy or debulking
Other
* No concurrent experimental mucosal protectants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00014118
Study Brief:
Protocol Section:
NCT00014118