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RECRUITING

NCT05547529

PHASE3

The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer

Sponsor: Blokhin's Russian Cancer Research Center

View on ClinicalTrials.gov

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).

Official title: An Open-Label Randomized Clinical Trial to Evaluate the Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer cT3-4aN0M0, cT1-4aN1-3M0.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2022-09-14

Completion Date

2027-09-14

Last Updated

2022-10-04

Healthy Volunteers

Yes

Conditions

Esophageal Cancer

Interventions

PROCEDURE

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

PROCEDURE

Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

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.

Locations (1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, Russia