Last updated: October 2, 2022
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Recruiting
Phase
3
Condition
Esophageal Cancer
Digestive System Neoplasms
Esophageal Disorders
Treatment
N/AClinical Study ID
NCT05547529
ENCHENEC
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent.
- Histologically confirmed squamous cell carcinoma of the esophagus.
- Clinical stage cT1-4aN1-3M0 (AJCC/UICC 8th Edition).
- Indications for surgical esophageal resection
- ECOG status 0-1.
- Adequate bone marrow function (White Blood Cells > 3.0 x 109/L; Neutrophil > 2.0 × 109/L; Hemoglobin > 90 g/L; Platelets > 100 x 109/L).
- Adequate liver function (Total bilirubin < 1.5 x Upper Level of Normal (ULN);Aspartate transaminase (AST) and Alanine transaminase (ALT) < 3.0 x ULN);
- Adequate renal function (Glomerular filtration rate (CCr) > 50 ml/min.
- Adequate cardiac function. Left ventricular ejection fraction > 50%.
- Age from 18 years to 70
Exclusion
Exclusion Criteria:
- Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition).
- Patients with advanced non-operable or metastatic esophageal cancer.
- Patients who have received or are receiving other chemotherapy, radiotherapy ortargeted therapy.
- Patients with another previous or current malignant disease.
- Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin orFluoruracil.
- Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive.
- Severe concomitant diseases (uncontrolled arterial hypertension, diabetes mellitus,stroke less than 6 months old, mental disorders, other tumors, etc.).
- Clinically significant coronary artery disease (NYHA III / IV), congestive heartfailure (NYHAIII / IV), clinically significant cardiomyopathy, myocardial infarctionwithin the last 6 months, or high risk of uncontrolled arrhythmia.
- Chronic inflammatory diseases of the gastrointestinal tract
- Acute infectious diseases.
- Pregnancy or breast feeding.
- Serious concomitant physical and mental illness / abnormalities or territorial reasonsthat may prevent the patient from participating in the protocol and adherence to theprotocol schedule.
- Foreigners or persons with limited legal rights.
- Any medical, geographic, or social circumstance, that in the opinion of theinvestigator excludes the patient's participation in the protocol.
Study Design
Total Participants: 156
Study Start date:
September 14, 2022
Estimated Completion Date:
September 14, 2027
Study Description
Connect with a study center
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478
Russian FederationActive - Recruiting

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