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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00077103
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following:
* Regionally advanced disease
* Confined to the neck and/or superior mediastinum (i.e., above the level of the carina)
* Measurable or evaluable\* disease
* Completely resected disease without measurable or evaluable disease NOTE: \*At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed
* Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry
* Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy
* Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction
* No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases
* Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8.5 g/dL
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST ≤ 3.5 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* LVEF ≥ 50% by echocardiogram
* EKG normal
* No prior angina
* No prior myocardial infarction (e.g., significant Q waves), QTc \> 450 msec, or other clinically significant abnormalities on ECG
* No congestive heart failure
* No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following:
* Conduction abnormality
* Nodal junctional arrhythmias and dysrhythmias
* Sinus bradycardia or tachycardia
* Supraventricular arrhythmias
* Atrial fibrillation or flutter
* Syncope or vasovagal episodes
* No significant heart wall abnormality or heart muscle damage by echocardiogram
* No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
* Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry
* No symptomatic peripheral vascular disease or cerebrovascular disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled hypokalemia or hypomagnesemia
* No concurrent serious infection
* No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy
* No grade 2 or greater pre-existing motor or sensory peripheral neuropathy
* No psychiatric disorder or other condition that would preclude study compliance
* No conditions associated with QTc prolongation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy, except for the following:
* Gonadotropin-releasing hormone agonists for patients with hormone-refractory prostate cancer
* Hormone replacement therapy
* Oral contraceptives
* Megestrol for anorexia/cachexia
Radiotherapy
* No prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* Prior attempt at resection or cytoreduction (e.g., debulking) surgery irrespective of surgical margins allowed provided there are no distant metastases
* At least 1 week but no more than 8 weeks since prior surgery and recovered
Other
* No other concurrent cytotoxic therapy
* No other concurrent antineoplastic therapy
* No other concurrent investigational therapy
* No concurrent medications known to prolong the QTc interval unless the medication can be held for at least 4 days during each treatment course
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00077103
Study Brief:
Protocol Section:
NCT00077103