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

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/A

Clinical Study ID

NCT05547529
ENCHENEC
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

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

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.

Connect with a study center

  • N.N. Blokhin National Medical Research Center of Oncology

    Moscow, 115478
    Russian Federation

    Active - Recruiting

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