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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT00054561
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Primary site must be within the oral cavity, oropharynx, larynx, or hypopharynx
* Stage III or IV primary lesion at diagnosis
* No distant metastatic disease at diagnosis
* No multiple primary lesions
* Currently disease-free after treatment with 1 of the following:
* Complete tumor resection
* Radiotherapy or chemoradiotherapy alone\*
* Resection followed by radiotherapy/chemoradiotherapy\*
* No more than 4-16 weeks since prior surgery and/or radiotherapy/chemoradiotherapy NOTE: \*Radiotherapy must have been 70-72 Gy in 1.8-2.0 Gy fractions to the primary tumor and clinically positive neck nodes and 44-50 Gy in 1.8-2.0 Gy fractions to clinically negative nodes, including the lower neck
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
Renal
* Creatinine no greater than 1.2 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month prior to, during, and for 1 month after study therapy
* Electrolytes normal
* Fasting serum triglyceride level no greater than 2 times ULN (anti-triglyceride medication allowed)
* No other malignancy within the past 2 years except localized basal cell or squamous cell skin cancer
* No other concurrent medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* Prior neoadjuvant chemotherapy allowed
* Prior chemotherapy administered concurrently with radiotherapy allowed
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* No history of megadose vitamin A (more than 25,000 I.U.)
* No other clinical trial enrollment that would preclude adjuvant systemic therapy
* No concurrent vitamin supplements containing vitamin A
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00054561
Study Brief:
Protocol Section:
NCT00054561