Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer (CELAEC)

December 1, 2020 updated by: The First Affiliated Hospital of Henan University of Science and Technology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited.

Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT).

Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients.

Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • Anyang Tumor Hospital
        • Contact:
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
        • Sub-Investigator:
          • Guoqiang Kong, MD
        • Sub-Investigator:
          • Xiaozhi Yuan, MD
        • Sub-Investigator:
          • Ruina Yang, MD
        • Sub-Investigator:
          • Jing Ren, MD
        • Sub-Investigator:
          • Wei Wang, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruinuo Jia, MD
        • Sub-Investigator:
          • Xinshuai Wang, MD, PhD
        • Sub-Investigator:
          • Baoping Chang, MD, PhD
        • Sub-Investigator:
          • Jiachun Sun, MD, PhD
        • Sub-Investigator:
          • Dan Zhou, MD
        • Sub-Investigator:
          • Shuoguo Li, MD
        • Sub-Investigator:
          • Shiyuan Song, MD
        • Sub-Investigator:
          • Weijiao Yin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CRT group
3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in IMRT mode (total of 50Gy given in 25 fractions) will be given over a period 5-6 weeks.
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

Other Names:
  • concurrent chemoradiotherapy
Active Comparator: Surgery group
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Procedure: surgery
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Other Names:
  • esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year disease-free survival rate
Time Frame: 2 year
The percent of 2 year disease-free survival after random allocation, percent
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events
Time Frame: 2 year
The percent of treatment-related adverse events after 2 year random allocation, percent
2 year
QoF (quality of life)
Time Frame: 2 year
The quality of life evaluation after 2 year of random allocation by questionnaire, 1-10 score, 1 means poor and 10 means best
2 year
2 year overall survival
Time Frame: 2 year
The percent of 2 year overall survival after random allocation, percent
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Collaborators

Jiangsu HengRui Medicine Co., Ltd.
Anyang Tumor Hospital
150th Hospital of PLA

Investigators

  • Study Chair: Shegan Gao, MD, PhD, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
  • Study Chair: Fuyou Zhou, MD, PhD, Anyang Tumor Hospital
  • Principal Investigator: Ruinuo Jia, MD, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 6, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTESC6111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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