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

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Sponsored by
Blokhin's Russian Cancer Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • N.N. Blokhin National Medical Research Center of OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Neoadjuvant Chemoradiotherapy

Neoadjuvant Chemotherapy

Arm Description

Carboplatin (AUC 2 mg/mL per min) and Paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. A total radiation dose of 41,4 Gy was given in 23 fractions of 1,8 Gy, 5 days per week. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.

4 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/ day for 5 days) every 3 weeks. Patients with dysphagia 3 оr with weight loss more then 10% 6 cycles of modified-DCF regimen will be performed (mDCF, docetaxel 50 mg/m2 day, CDDP 50 mg/m2 day and 5-FU at 2400 mg/m2/day for 2 days) every 3 weeks. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.

Outcomes

Primary Outcome Measures

Disease-free survival
Survival without local or systemic recurrence

Secondary Outcome Measures

Overall survival
Overall survival of patients
Treatment related complications
Сomplications after treatment
Number of cycles, frequency of neoadjuvant therapy reduction
Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions
Correlation between genetic profile and tumor response
Influence of the genetic profile on the tumor response
Pathological response rate(pCR)
Frequency of pathological pathomorphosis
R0 resection rate
Residual tumor rate

Full Information

First Posted
September 14, 2022
Last Updated
October 2, 2022
Sponsor
Blokhin's Russian Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05547529
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
September 14, 2025 (Anticipated)
Study Completion Date
September 14, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blokhin's Russian Cancer Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant Chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Carboplatin (AUC 2 mg/mL per min) and Paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. A total radiation dose of 41,4 Gy was given in 23 fractions of 1,8 Gy, 5 days per week. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.
Arm Title
Neoadjuvant Chemotherapy
Arm Type
Experimental
Arm Description
4 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/ day for 5 days) every 3 weeks. Patients with dysphagia 3 оr with weight loss more then 10% 6 cycles of modified-DCF regimen will be performed (mDCF, docetaxel 50 mg/m2 day, CDDP 50 mg/m2 day and 5-FU at 2400 mg/m2/day for 2 days) every 3 weeks. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.
Intervention Type
Procedure
Intervention Name(s)
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Intervention Description
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Intervention Type
Procedure
Intervention Name(s)
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Intervention Description
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Survival without local or systemic recurrence
Time Frame
3(5) years after last patient enrolled
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival of patients
Time Frame
3(5) years after last patient enrolled
Title
Treatment related complications
Description
Сomplications after treatment
Time Frame
During the procedure
Title
Number of cycles, frequency of neoadjuvant therapy reduction
Description
Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions
Time Frame
During the procedure
Title
Correlation between genetic profile and tumor response
Description
Influence of the genetic profile on the tumor response
Time Frame
Immediately after the procedure
Title
Pathological response rate(pCR)
Description
Frequency of pathological pathomorphosis
Time Frame
Immediately after the surgery
Title
R0 resection rate
Description
Residual tumor rate
Time Frame
Immediately after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Abouhaidar, MD, PhD
Phone
+79269125902
Email
abouhaidar@yandex.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Parvin Akhmedov
Phone
+79267333323
Email
Akhmedovparvin@gmail.com
Facility Information:
Facility Name
N.N. Blokhin National Medical Research Center of Oncology
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Kononets
First Name & Middle Initial & Last Name & Degree
Pavel Kononets
First Name & Middle Initial & Last Name & Degree
Omar Abouhaidar
First Name & Middle Initial & Last Name & Degree
Parvin Akhmedov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share personal patient data

Learn more about this trial

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

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