Comparing neoadjuvant chemoradiotherapy and chemotherapy for esophageal cancer treatment

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.

This study is testing whether a combination of chemotherapy and radiation before surgery is better than just chemotherapy before surgery for people with advanced esophageal cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Blokhin's Russian Cancer Research Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Moscow)
• Trial ID: NCT05547529 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of neoadjuvant chemoradiotherapy followed by esophagectomy compared to neoadjuvant chemotherapy followed by esophagectomy in patients with locally advanced resectable esophageal squamous cell carcinoma. A total of 156 patients will be randomly assigned to either treatment group in a 1:1 ratio. The study aims to determine if neoadjuvant chemoradiotherapy offers any advantages over chemotherapy in terms of patient outcomes and safety. It is a phase III non-inferiority trial sponsored by the N.N. Blokhin NMRC of Oncology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed locally advanced resectable esophageal squamous cell carcinoma.

Not a fit: Patients with advanced non-operable or metastatic esophageal cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective pre-surgical treatment for esophageal cancer, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored similar treatment approaches, but this specific comparison of neoadjuvant chemoradiotherapy versus chemotherapy in this patient population is novel.

Eligibility criteria

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.

Where this trial is running

Moscow

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

Study contacts

• Study coordinator: Omar Abouhaidar, MD, PhD

Conditions Esophageal Cancer