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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00033657
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction
* Stage T2-3, N0, M0 OR
* Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)
* Tumor must be considered surgically resectable (T1-3, but not T4)
* Age\>=18 years
* ECOG Performance status 0-1
* Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization:
* Granulocyte count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years
* Fertile patients must use effective contraception
* Endoscopy with biopsy and dilation allowed
Exclusion Criteria:
* Tumor extends more than 2 cm into the cardia
* Pregnant or nursing
* Other concurrent illness that would preclude study therapy or surgical resection
* Concurrent filgrastim (G-CSF) during study radiotherapy
* Prior chemotherapy
* Prior radiotherapy
* Prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00033657
Study Brief:
Protocol Section:
NCT00033657