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Tests treatment safety and results for Esophageal Cancer
Official title The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
ClinicalTrials.gov ID: NCT05547529
What this study is testing
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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...
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.