NCT05547529RecruitingPhase 3
The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
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.
Source: ClinicalTrials.gov · Last updated 4 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 14 Sept 2022
- Start date
- 14 Sept 2022
- Primary completion date
- 14 Sept 2025
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05547529
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 156
- From 14 Sept 2022 to the primary completion date, 14 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy.
- Patients with another previous or current malignant disease.
- Severe concomitant diseases (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors, etc.).
- 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.
Other illness
- Patients with advanced non-operable or metastatic esophageal cancer.
- 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.
- 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.
Other
- Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition).
- Pregnancy or breast feeding.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| N.N.Blokhin National Medical Research Center of Oncology Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.