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

Recruiting now · Phase 3

Conditions studied: Esophageal Cancer

In brief

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).

Key facts

Study ID

NCT05547529

Run by

Blokhin's Russian Cancer Research Center

People needed

156

Starts

2022-09-14

Expected to finish

2027-09-14

Last updated by the study team

2022-10-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• N.N. Blokhin National Medical Research Center of Oncology — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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