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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT00646659
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed squamous cell carcinoma of the head and neck
* Stage III or IV disease
* Unresectable disease
* Unidimensionally or bidimensionally measurable disease
* Skin and tumor material must be available for EGFR status and downstream signaling studies
* No nasopharyngeal, nasal, or paranasal cancer
* No distant metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* Alkaline phosphatase and transaminases ≤ 2.5 times ULN
* Serum creatinine ≤ 120 μmol/L (1.36 mg/dL)
* Creatinine clearance ≥ 60 mL/min
* Normal cardiac function (i.e., LVEF ≥ 50%)
* Clinically satisfactory 12-lead ECG
* No serious cardiac illness or medical condition within the past 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No current malignancies at other sites with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least the past five years
* No unstable systemic diseases
* No active uncontrolled infections
* No psychological, familial, sociological, or geographical condition that would preclude compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior treatment for head and neck cancer
* No other concurrent anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00646659
Study Brief:
Protocol Section:
NCT00646659