RECRUITINGPhase 3INTERVENTIONAL
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.
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- Written willing to sign a consent form.
- diagnosed by tissue sample (biopsy-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
Who Should NOT Join This Trial:
- 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 weakened immune system 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
PROCEDURE
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
PROCEDURE
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Locations (1)
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia