Actively Recruiting
The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
Led by Blokhin's Russian Cancer Research Center · Updated on 2022-10-04
156
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 10^9/L; Neutrophil > 2.0 x 10^9/L; Hemoglobin > 90 g/L; Platelets > 100 x 10^9/L).
- Adequate liver function (Total bilirubin < 1.5 x Upper Level of Normal; AST and ALT < 3.0 x ULN).
- Adequate renal function (Glomerular filtration rate > 50 ml/min).
- Adequate cardiac function. Left ventricular ejection fraction > 50%.
- Age from 18 years to 70.
You will not qualify if you...
- Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition).
- Advanced non-operable or metastatic esophageal cancer.
- Previous or current treatment with chemotherapy, radiotherapy, or targeted therapy.
- Another previous or current malignant disease.
- Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin, or Fluoruracil.
- Active infection with HIV, hepatitis B, or hepatitis C; positive for HIV, HBV DNA, or HCV RNA.
- Severe concomitant diseases (uncontrolled hypertension, diabetes, recent stroke, mental disorders, other tumors).
- Significant coronary artery disease or heart failure (NYHA III/IV), recent myocardial infarction, or high risk of arrhythmia.
- Chronic inflammatory diseases of the gastrointestinal tract.
- Acute infectious diseases.
- Pregnancy or breastfeeding.
- Serious physical or mental illness or conditions preventing adherence to the protocol.
- Foreigners or persons with limited legal rights.
- Any other medical, geographic, or social condition excluding participation as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia, 115478
Actively Recruiting
Research Team
O
Omar Abouhaidar, MD, PhD
CONTACT
P
Parvin Akhmedov
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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