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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT00445861
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus
* Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed
* Locally advanced disease
* Obstructive tumors are considered locally advanced disease
* Meets 1 of the following staging criteria:
* T3, N0 disease
* T1-3, N1 disease
* T4, N0-1 disease
* Resectable disease
* No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
* No airway infiltration in case of tumors of the upper third of the thoracic esophagus
* No cervical esophageal carcinoma
* No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Creatinine clearance \> 60 mL/min
* Bilirubin normal
* Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
* AST ≤ 1.5 times ULN
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer
* No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:
* New York Heart Association class III or IV congestive heart failure
* Unstable angina pectoris
* Myocardial infarction within the past 3 months
* Significant arrhythmias
* No psychiatric disorder that would preclude study compliance
* No active uncontrolled infection
* No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
* No peripheral neuropathy \> grade 1
* No contraindications to corticosteroids
* No known hypersensitivity to any component of the study drugs
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
* No prior radiotherapy to the chest
* No participation in another clinical trial within the past 30 days
* No other concurrent experimental drugs or anticancer therapy
* No concurrent drugs contraindicated for use with the study drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00445861
Study Brief:
Protocol Section:
NCT00445861