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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT00352118
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Stage IVA or IVB disease
* Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
* Measurable or evaluable disease
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
* Bilirubin normal
* Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
Exclusion Criteria:
* Salivary gland, sinus, or nasopharyngeal primary disease
* Evidence of distant metastatic disease
* Pregnant or nursing
* Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
* Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
* Peripheral neuropathy ≥ grade 2
* Hearing loss ≥ grade 2
* Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
* Poor nutritional status, in the opinion of the investigator
* Active infection
* Active ischemic heart disease
* Myocardial infarction within the past 6 months
* Prior radiotherapy above the clavicles
* Prior chemotherapy
* Prior surgery to the primary tumor except biopsy
* Concurrent amifostine or other investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00352118
Study Brief:
Protocol Section:
NCT00352118