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Trial Title:
The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
NCT ID:
NCT05547529
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Description:
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown
esophagectomy.
Arm group label:
Neoadjuvant Chemoradiotherapy
Intervention type:
Procedure
Intervention name:
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Description:
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Arm group label:
Neoadjuvant Chemotherapy
Summary:
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).
Detailed description:
It is a prospective open-label randomized phase III clinical trial sponsored by N.N.
Blokhin NMRC of Oncology. 156 patients with locally advanced resectable esophageal
squamous cell carcinoma (cT3-4aN0M0, cT1-4aN1-3M0) are recruited and randomly assigned
into the neoadjuvant chemoradiotherapy group (nCRT) followed by esophagectomy and the
neoadjuvant chemotherapy group (nCT) followed by esophagectomy according to the
proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are
compared between the two regimens.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
N.N. Blokhin National Medical Research Center of Oncology
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Pavel Kononets
Investigator:
Last name:
Pavel Kononets
Email:
Principal Investigator
Investigator:
Last name:
Omar Abouhaidar
Email:
Sub-Investigator
Investigator:
Last name:
Parvin Akhmedov
Email:
Sub-Investigator
Start date:
September 14, 2022
Completion date:
September 14, 2027
Lead sponsor:
Agency:
Blokhin's Russian Cancer Research Center
Agency class:
Other
Source:
Blokhin's Russian Cancer Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05547529
