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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT00084435
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of squamous cell carcinoma of the head and neck
* Selected stage III or IV (no distant metastasis) disease
* The following TNM stages are excluded:
* T3, N0, M0
* T4a, N0, M0
* T4b, N3, M0
* Any T, any N, M1
* Complete total resection within the past 56 days AND has one or more of the following risk factors:
* Multiple pathologically confirmed lymph node metastases
* One or more lymph nodes with extracapsular extension of tumor
* Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection
* No primary nasopharyngeal carcinoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* SGOT or SGPT ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Other
* No pre-existing peripheral neuropathy
* No known history of severe hypersensitiviy reaction to products containing Polysorbate 80
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for the malignancy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for the malignancy
Surgery
* See Disease Characteristics
Other
* No concurrent amifostine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00084435
Study Brief:
Protocol Section:
NCT00084435