RecruitingNot ApplicableNCT02972372

Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients


Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Enrollment

196 participants

Start Date

Nov 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for locally advanced esophageal (food pipe) cancer: a combination of chemotherapy and radiation therapy versus surgery to remove the tumor, to see which leads to better outcomes. **You may be eligible if...** - You are of Chinese ethnicity - You have been diagnosed with squamous cell cancer of the esophagus (a specific type of food-pipe cancer) - Your tumor is in the middle or lower part of the esophagus - Surgery to remove the tumor is possible (or potentially possible) - Your cancer stage is within certain locally advanced categories (no distant spread) **You may NOT be eligible if...** - Cancer has spread to distant organs (like the liver or lungs) - Cancer has grown into the windpipe, major blood vessels, or nerves near the voice box - You have serious other medical conditions or are too unwell to safely have chest surgery 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

PROCEDURECRT

Drug: Capecitabine(Aibin) capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 weeks in total Other Names: Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng):65mg/m2,d1,8, 22, 29,I.V. Other Names: Aiheng cisplatin: 75mg/m2 d1,29 or d1, 29, 57, 85. 5-Fu:750mg/m2 CIV24h d1-4,d29-32 or d1-4,d29-32, d57-60, d85-88. Radiation: Radiotherapy concurrent radiotherapy:IMRT radiotherapy 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity

PROCEDUREsurgery

The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy


Locations(2)

Anyang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Luoyang, Henan, China

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NCT02972372


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