Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

NCT02972372 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Phase

Not applicable

Started

2016-11

Last updated

2025-02-10

Condition(s) studied

Esophagus Cancer

Investigational drug(s) / intervention(s)

CRTsurgery

CRT: 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

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

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Chinese * esophageal squamous cell cancer * mid or lower esophageal cancer * tumor is resectable disease * clinical stage: cT1bN+Mo, or cT2-4aN0-2M0 Exclusion Criteria: * who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve. * who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

Primary outcome measure(s)

2-year disease-free survival rate — 2 year
The percent of 2 year disease-free survival after random allocation, percent

Trial sites (2)

Facility	City	Region	Status
Anyang Tumor Hospital	Anyang	Henan	Recruiting
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology	Luoyang	Henan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02972372 on ClinicalTrials.gov ↗ ← All trials in China