The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy., Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- 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
Primary outcome measures
- Disease-free survival [Time frame: 3(5) years after last patient enrolled]
Secondary outcome measures (6)
- Overall survival [Time frame: 3(5) years after last patient enrolled]
- Treatment related complications [Time frame: During the procedure]
- Number of cycles, frequency of neoadjuvant therapy reduction [Time frame: During the procedure]
- Correlation between genetic profile and tumor response [Time frame: Immediately after the procedure]
- Pathological response rate(pCR) [Time frame: Immediately after the surgery]
- R0 resection rate [Time frame: Immediately after the surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- N.N. Blokhin National Medical Research Center of Oncology — Moscow
Identifiers
NCT: NCT05547529 · ENCHENEC