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Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

NCT02972372 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-02-10

No results posted yet for this 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.

Conditions

  • Esophagus Cancer

Interventions

PROCEDURE

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

PROCEDURE

surgery

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Anyang Tumor Hospital

    collaborator OTHER

  • 150th Hospital of PLA

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Henan University of Science and Technology

    lead OTHER

Principal Investigators

  • Shegan Gao, MD, PhD · The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

  • Fuyou Zhou, MD, PhD · Anyang Tumor Hospital

  • Ruinuo Jia, MD · The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02972372 on ClinicalTrials.gov