Clinical trial NCT05547529: The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Cancer
Lead sponsor: Blokhin's Russian Cancer Research Center
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Disease-free survival
timeFrame: 3(5) years after last patient enrolled
Secondary outcomes:
measure: Overall survival
timeFrame: 3(5) years after last patient enrolled
measure: Treatment related complications
timeFrame: During the procedure
measure: Number of cycles, frequency of neoadjuvant therapy reduction
timeFrame: During the procedure
measure: Correlation between genetic profile and tumor response
timeFrame: Immediately after the procedure
measure: Pathological response rate(pCR)
timeFrame: Immediately after the surgery
measure: R0 resection rate
timeFrame: Immediately after the surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.N. Blokhin National Medical Research Center of Oncology
Study officials:
References: