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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00701857
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of esophageal or gastroesophageal junction carcinoma
* Stage III or IV disease
* Treatment with chemoradiotherapy is considered appropriate
* Measurable or evaluable disease
* Clinically significant pleural or pericardial effusions or ascites allowed provided they were drained prior to study entry
* No pleurodesis within the past 2 weeks
* Controlled brain metastasis allowed provided patient is clinically stable with no signs of progression by MRI or CT scan of the brain ≥ 60 days after completion of treatment AND is asymptomatic and does not require steroids
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* WBC ≥ 2,500/mm\^3
* ANC ≥ 1,500/mm\^3
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin normal
* Alkaline phosphatase AND AST and ALT meeting the following criteria:
* Alkaline phosphatase normal AND AST or ALT ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastases)
* Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
* Creatinine clearance ≥ 45 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* Able to take folic acid, vitamin B\_12, or corticosteroids
* No known severe hypersensitivity reaction to study drugs
* No uncontrolled serious active infection
* No pre-existing peripheral neuropathy \> grade 1
* No significant cardiac disease, including any of the following:
* Uncontrolled high blood pressure
* Unstable angina
* Congestive heart failure within the past 6 months
* Left ventricular ejection fraction below the lower limit of normal
* Myocardial infarction within the past year
* Serious cardiac arrhythmias requiring medication
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior systemic therapy regimens
* No prior radiotherapy to gastric/esophageal fields
* No aspirin or other NSAID before and after pemetrexed disodium administration
* No concurrent colony-stimulating factors (CSF) to maintain WBC and ANC eligibility values
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00701857
Study Brief:
Protocol Section:
NCT00701857