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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00139269
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (SSCHN).
* At least one bi- or uni-dimensionally measurable lesion.
* Stage II or IV disease without evidence of distant metastasis.
* No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.
* Age greater than 18 years.
* ECOG performance status of 0 or 1.
* Life expectancy of greater than 12 weeks.
* Adequate bone marrow, hepatic and renal function.
* Normal serum calcium
Exclusion Criteria:
* Primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
* Patients with any non-SSCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
* Any prior treatment with chemotherapy.
* Prior radiotherapy to major bone marrow area (\> 10% bone marrow) or to head and neck.
* Current peripheral neuropathy of greater than NCI grade 2.
* Other serious illness or medical condition
* Concurrent treatment with corticosteroids unless chronic treatment at low doses.
* Pregnant or lactating females or females of childbearing potential not employing adequate contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00139269
Study Brief:
Protocol Section:
NCT00139269