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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT00080028
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Each patient must sign a study-specific informed consent form
* Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
* Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
* Karnofsky Performance Status score of at least 60%
* Primary tumor at least 4 cm in diameter
Exclusion Criteria:
Laboratory Values of:
* Serum creatinine \> 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
* Serum total bilirubin \> 1.5 times the upper limit of normal
* ALT (formerly SGPT) \> 1.5 times the upper limit of normal
* Alkaline phosphatase \> 1.5 times the upper limit of normal
* Absolute neutrophil count (ANC) \< 1500/L
* Platelet count \< 100,000/L
* 3+ or greater proteinuria on urinalysis
and
* Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx
* Distant metastases
* Prior history of cancer at any site treated with radiotherapy and/or chemotherapy
* History of SCCHN diagnosed within 5 years of current diagnosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00080028
Study Brief:
Protocol Section:
NCT00080028