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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT00559351
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
* Patients' age above 18 years
* General condition with Karnofsky performance status of \>70
* Circulatory and pulmonary capacity at normal range (FEV1 \>60%; FVC \>60%, NYHA I-II, cardiac output \>40%)
* Normal function of the bone marrow (RBC \>3,5 T/l; PLT \>100 G/l)
* Normal renal (creatinine \<1.5 of the upper limit) and liver (AST or ALT \<2,5 of the upper limit or bilirubin \<1,5 of the upper limit) function
Exclusion Criteria:
* Metastatic disease
* Synchronous malignancy
* History of other cancer within 5 years prior to esophageal cancer treatment
* History of allergic reaction to cisplatin of 5-fluorouracil
* Systemic infection
* Pregnancy or female patients in childbearing age without proper contraceptives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00559351
Study Brief:
Protocol Section:
NCT00559351