The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer

Esophageal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547529
• Other study ID #: ENCHENEC
• Status: Recruiting
• Phase: Phase 3
• Start date: September 14, 2022
• Est. completion date: September 14, 2027

Study information

• Verified date: September 2022
• Source: Blokhin's Russian Cancer Research Center
• Contact: Omar Abouhaidar, MD, PhD
• Phone: +79269125902
• Email: abouhaidar[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: September 14, 2027
• Est. primary completion date: September 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Procedure:
• Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
• Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin National Medical Research Center of Oncology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Survival without local or systemic recurrence	3(5) years after last patient enrolled
Secondary	Overall survival	Overall survival of patients	3(5) years after last patient enrolled
Secondary	Treatment related complications	?omplications after treatment	During the procedure
Secondary	Number of cycles, frequency of neoadjuvant therapy reduction	Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions	During the procedure
Secondary	Correlation between genetic profile and tumor response	Influence of the genetic profile on the tumor response	Immediately after the procedure
Secondary	Pathological response rate(pCR)	Frequency of pathological pathomorphosis	Immediately after the surgery
Secondary	R0 resection rate	Residual tumor rate	Immediately after the surgery