Comparing neoadjuvant chemoradiotherapy and chemotherapy for esophageal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Omar Abouhaidar, MD, PhD
• Email: abouhaidar@yandex.ru
• Phone: +79269125902

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PF-08098488 in adults with advanced solid tumors

  This study tests PF-08098488 in adults whose cancer has progressed or returned after prior treatment.

  Recruiting at 4 sites Phase 1 Pfizer · Grand Rapids, Michigan and 3 other locations · NCT07903415

• Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

  This trial tests whether modular robotic-assisted esophagectomy using the Carina platform works better than conventional 3D thoracoscopic esophagectomy for people with resectable esophageal cancer.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT07888140

• MGC030 in adults with advanced solid tumors

  This trial tests MGC030 in adults with advanced urothelial, gastric/GEJ, esophageal, colorectal, gastric, pancreatic, or GEJ cancers to see if it is safe and whether it can shrink tumors or stop growth.

  Recruiting Phase 1 MacroGenics · Lake Success, New York · NCT07822399

• Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer

  This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.

  Recruiting at 7 sites Phase 1/2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07818018

• TS-104: a first-in-human, dose-escalation study for advanced solid tumors

  This study tests TS-104, a peptide-drug conjugate, as a single therapy in adults with advanced solid tumors like NSCLC, HNSCC, esophageal, gastric, ovarian, or endometrial cancer to see if it is safe and tolerable and whether it shows any benefit.

  Recruiting at 3 sites Phase 1 TwoStep Therapeutics, Inc. · Maumee, Ohio and 2 other locations · NCT07814248

• First-in-human STRO-006 in adults with certain recurrent or metastatic solid tumors

  This study tests STRO-006 alone and with pembrolizumab in adults with certain head and neck, lung, esophageal, gastric, colorectal cancers to see if it is safe and shows early anticancer activity.

  Recruiting at 3 sites Phase 1 Sutro Biopharma, Inc. · Orlando, Florida and 5 other locations · NCT07807345

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.