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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT03579004
Eligibility Criteria:
Inclusion Criteria:
1. age 18-75
2. Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
3. No prior antineoplastic treatment
4. Eastern Cooperative Oncology Group (ECOG) status 0-2
5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy
* absolute neutrophil count ≥ 1,500 х109/l
* thrombocytes ≥ 100 х 109/l
* hemoglobin ≥ 90 mg/l
* creatinine \< 115 µmol/л or creatinine clearance ≥ 55 ml/min
* alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN)
* alkaline phosphatase (ALP) \> 5 x ULN
* bilirubin \> 1,5 х ULN
6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
7. Patients must follow appropriate contraception rules during whole treatment period
8. Decrease of body weight must not be more than 20% in last 6 months
Exclusion Criteria:
1. Presence of distant metastases except for metastatic supraclavicular lymphnodes;
2. Bulky (\>3 cm) regional lymphnodes metastases;
3. Cervical esophageal cancer;
4. Presence of tumor fistula;
5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03579004
Study Brief:
Protocol Section:
NCT03579004