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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05547529
Other study ID # ENCHENEC
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 14, 2022
Est. completion date September 14, 2027

Study information

Verified date September 2022
Source Blokhin's Russian Cancer Research Center
Contact Omar Abouhaidar, MD, PhD
Phone +79269125902
Email abouhaidar@yandex.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. This is non-inferiority study (neoadjuvant chemoradiotherapy has no advantage over neoadjuvant chemotherapy).


Description:

It is a prospective open-label randomized phase III clinical trial sponsored by N.N. Blokhin NMRC of Oncology. 156 patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0M0, cT1-4aN1-3M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (nCRT) followed by esophagectomy and the neoadjuvant chemotherapy group (nCT) followed by esophagectomy according to the proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are compared between the two regimens.


Recruitment information / eligibility

Status Recruiting
Enrollment 156
Est. completion date September 14, 2027
Est. primary completion date September 14, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 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 or targeted therapy. - Patients with another previous or current malignant disease. - Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin or Fluoruracil. - 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 heart failure (NYHAIII / IV), clinically significant cardiomyopathy, myocardial infarction within 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 reasons that may prevent the patient from participating in the protocol and adherence to the protocol schedule. - Foreigners or persons with limited legal rights. - Any medical, geographic, or social circumstance, that in the opinion of the investigator excludes the patient's participation in the protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Locations

Country Name City State
Russian Federation N.N. Blokhin National Medical Research Center of Oncology Moscow

Sponsors (1)

Lead Sponsor Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival Survival without local or systemic recurrence 3(5) years after last patient enrolled
Secondary Overall survival Overall survival of patients 3(5) years after last patient enrolled
Secondary Treatment related complications ?omplications after treatment During the procedure
Secondary Number of cycles, frequency of neoadjuvant therapy reduction Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions During the procedure
Secondary Correlation between genetic profile and tumor response Influence of the genetic profile on the tumor response Immediately after the procedure
Secondary Pathological response rate(pCR) Frequency of pathological pathomorphosis Immediately after the surgery
Secondary R0 resection rate Residual tumor rate Immediately after the surgery
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