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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT00665392
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the oropharynx
* Stage III (T3 or T1-2, N1-2, M0) or nonmetastatic stage IV (T4 or T1-3, N3, M0) disease
* Resectable disease
* Measurable or evaluable disease
* Tumor tissue available
PATIENT CHARACTERISTICS:
Inclusion criteria:
* WHO performance status 0-1
* ANC ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Hemoglobin ≥ 9 g/dL
* Creatinine \< 1.5 times upper limit of normal (ULN)
* Creatinine clearance ≥ 60 mL/min
* AST and ALT \< 5 times ULN
* Bilirubin \< 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Affiliated with social security (including CMU)
Exclusion criteria:
* Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
* Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy)
* Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix
* Auditory condition precluding the use of cisplatin
* Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment
* Persons under guardianship or trusteeship, or prisoners of law
PRIOR CONCURRENT THERAPY:
* No prior treatment, including chemotherapy or radiotherapy
* No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00665392
Study Brief:
Protocol Section:
NCT00665392