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:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00061958
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
* Metastatic or unresectable local-regional disease
* Osseous metastasis as the only site of disease not eligible
* Measurable disease
* Mediastinal or hilar lymph nodes must be at least 2.0 cm in diameter by CT scan or MRI to be considered measurable
* No known brain metastases
* Performance status - Zubrod 0-2
* Performance status - Karnofsky 60-100%
* At least 12 weeks
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
* Bilirubin no greater than 1.5 mg/dL
* SGOT and/or SGPT no greater than 2.0 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min
* Calcium no greater than 12 mg/dL
* No symptomatic hypercalcemia under treatment
* No New York Heart Association class III or IV heart disease
* No angina within the past 6 months
* No myocardial infarction within the past 6 months
* No congestive heart failure within the past 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Prior malignancies with no evidence of disease for at least 2 years are allowed
* No serious concurrent infection that is uncontrolled or whose control could be jeopardized by complications of study therapy
* No concurrent nonmalignant medical illness that is uncontrolled or whose control could be jeopardized by complications of study therapy
* No psychiatric disorder or other condition that would preclude study compliance
* No prior immunotherapy (including adjuvant or preoperative regimens)
* No concurrent biological response modifiers
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* No prior chemotherapy (including adjuvant or preoperative regimens and radiosensitizers)
* At least 4 weeks since prior radiotherapy and recovered
* No prior radiotherapy to major bone marrow containing areas (e.g., pelvis or lumbar spine) or area that contained the indicator lesion
* No prior radiotherapy involving 30% or more of the bone marrow
* No concurrent radiotherapy
* At least 2 weeks since prior major surgery (4 days for minor surgery) and recovered
* No other concurrent investigational drugs
* No other concurrent antineoplastic therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00061958
Study Brief:
Protocol Section:
NCT00061958