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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00559156
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of head and neck cancer meeting the following criteria:
* Epidermoid carcinoma
* Stage III or IV disease
* Must have percutaneous gastrostomy tube in place
* Must have undergone prior surgery for head and neck cancer within the past 6-8 weeks
* No cerebral metastases
PATIENT CHARACTERISTICS:
* WHO performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 3 months
* WBC \> 4,000/mm³
* ANC \> 2,000/mm³
* Platelet count \> 100,000/mm³
* PTT ≥ 50%
* Creatinine \< 130 μmol/L
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe sepsis
* No requirement for parenteral nutrition
* No pre-existing digestive pathology that results in bowel obstruction, nausea, vomiting, and/or abdominal pain \> grade 1
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00559156
Study Brief:
Protocol Section:
NCT00559156