RecruitingPhase 3NCT05547529

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

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.


Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

156 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two pre-surgery treatment approaches for people with a type of esophageal (food pipe) cancer — squamous cell carcinoma: one group receives chemotherapy combined with radiation before surgery, while the other receives chemotherapy alone. The goal is to see which approach leads to better outcomes. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the esophagus confirmed by biopsy - Your cancer is at a resectable stage (able to be surgically removed) - You are between 18 and 70 years old - You are in good physical condition (ECOG 0–1) - Your blood counts, liver, kidney, and heart function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had previous chemotherapy or radiation for esophageal cancer - You have severe heart, liver, or kidney problems - You are pregnant - Your cancer involves the cervical esophagus only Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPatients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.

Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.

PROCEDUREPatients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy


Locations(1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, Russia

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NCT05547529


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