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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT00072033
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
* Locally advanced disease that is technically operable with curative intent (R0)
* T3, N0 OR T1-3, N+ OR T4, NX
* No T1-2, N0
* No inoperable T4 (unequivocal organ involvement)
* No distant metastasis, including M1a lymph node status
* Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
* No carcinoma of the cervical esophagus
* Obstructive tumors allowed
PATIENT CHARACTERISTICS:
Age
* 18 to 70
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* AST no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* Bilirubin no greater than 1.5 times ULN
Renal
* Creatinine clearance greater than 60 mL/min
Cardiovascular
* No New York Heart Association class III or IV congestive heart failure
* No unstable angina pectoris
* No myocardial infarction within the past 3 months
* No significant arrhythmias
* No other severe or uncontrolled cardiovascular disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after study treatment
* No definite contraindications to corticosteroids as premedication
* No geographic situation that would preclude proper staging and follow-up
* No active uncontrolled infection
* No preexisting peripheral neuropathy greater than grade 1
* No uncontrolled diabetes mellitus
* No active autoimmune disease
* No other serious medical condition that would preclude study participation
* No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
* No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the chest
Surgery
* Not specified
Other
* More than 30 days since prior treatment on another clinical trial
* No other concurrent experimental drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00072033
Study Brief:
Protocol Section:
NCT00072033