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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00077051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity or oropharynx
* Stage III disease not eligible for surgery
* Stage IV disease allowed if patient is not eligible for chemotherapy or refused chemotherapy
* No distant metastasis
* Previously untreated disease
* No osteoradionecrosis in patients with tumors involving the maxilla
* Tumor tissue/normal adjacent tissue (T/N) ratio for dC kinase and dCMP deaminase greater than 2.5
PATIENT CHARACTERISTICS:
Age
* Over 21
Performance status
* Karnofsky 80-100% OR
* ECOG 0-1
Life expectancy
* More than 6 months
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* WBC at least 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* AST/ALT less than 2.5 times upper limit of normal
* Bilirubin normal
Renal
* Creatinine normal OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No impending carotid rupture
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study treatment
* HIV negative
* No other concurrent uncontrolled illness
* No active or ongoing infection
* No alcohol dependence
* No psychiatric illness or social situation that would preclude study compliance
* No other malignancy within the past 3 years except low-risk, non-melanomatous skin cancer, carcinoma in situ (e.g., breast, cervix, or bladder), or stage T1-2, low-to-moderate grade prostate cancer (Gleason score no greater than 7)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy except contraceptives or replacement steroids
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No prior therapy for head and neck cancer
* No other concurrent experimental medications
* No other concurrent anticancer therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
120 Years
Study:
NCT00077051
Study Brief:
Protocol Section:
NCT00077051