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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT01258192
Eligibility Criteria:
Inclusion Criteria:
* Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.
* Age ranges from 18 to 70 years.
* Patients must not have received any prior anticancer therapy.
* Performance status of 0 to 1
* Estimated life expectancy of at least 6 months.
* Tumor can be measured according to RECIST criteria
* Signed informed consent document on file.
* Females with childbearing potential must have a negative serum pregnancy
* Adequate organ function including the following:
Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
Exclusion Criteria:
* Carcinoma at the upper part of esophagus
* Histologic diagnosis of adenocarcinoma of esophagus.
* Prior treatment for esophageal cancer.
* Active infection.
* Pregnant or breast feeding.
* History of significant neurological or mental disorder, including seizures or dementia.
* Prior invasive malignancy in 5 years (except for carcinoma in situ).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01258192
Study Brief:
Protocol Section:
NCT01258192