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Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer (CELAEC)

Primary Purpose

Esophagus Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CRT

surgery

About this trial

This is an interventional treatment trial for Esophagus Cancer focused on measuring esophageal cancer, chemoradiation, esophagectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Anyang Tumor HospitalRecruiting
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CRT group

Surgery group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

2-year disease-free survival rate

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

Secondary Outcome Measures

Treatment-related adverse events

The percent of treatment-related adverse events after 2 year random allocation, percent

QoF (quality of life)

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 overall survival

The percent of 2 year overall survival after random allocation, percent

Full Information

NCT ID

NCT02972372

First Posted

November 6, 2016

Last Updated

December 1, 2020

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

1. Study Identification

Unique Protocol Identification Number

NCT02972372

Brief Title

Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

Acronym

CELAEC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophagus Cancer

Keywords

esophageal cancer, chemoradiation, esophagectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CRT group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Surgery group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

CRT

Other Intervention Name(s)

concurrent chemoradiotherapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

surgery

Other Intervention Name(s)

esophagectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

2-year disease-free survival rate

Description

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

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Treatment-related adverse events

Description

The percent of treatment-related adverse events after 2 year random allocation, percent

Time Frame

2 year

Title

QoF (quality of life)

Description

The quality of life evaluation after 2 year of random allocation by questionnaire, 1-10 score, 1 means poor and 10 means best

Time Frame

2 year

Title

2 year overall survival

Description

The percent of 2 year overall survival after random allocation, percent

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shegan Gao, MD, PhD

Phone

+86 18638859977

gsg112258@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ruinuo Jia, MD

Phone

+86 18537950766

jiaruinuo@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shegan Gao, MD, PhD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Fuyou Zhou, MD, PhD

Organizational Affiliation

Anyang Tumor Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ruinuo Jia, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anyang Tumor Hospital

City

Anyang

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fuyou Zhou, MD,PhD

Phone

+86 13939998799

jiaruinuo@163.com

Facility Name

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

City

Luoyang

State/Province

Henan

ZIP/Postal Code

471003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shegan Gao, MD, PhD

Phone

+86 18638859977

gsg112258@163.com

First Name & Middle Initial & Last Name & Degree

Ruinuo Jia, MD

Phone

+86 18537950766

jiaruinuo@163.com

First Name & Middle Initial & Last Name & Degree

Ruinuo Jia, MD

First Name & Middle Initial & Last Name & Degree

Xinshuai Wang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Guoqiang Kong, MD

First Name & Middle Initial & Last Name & Degree

Baoping Chang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jiachun Sun, MD, PhD

First Name & Middle Initial & Last Name & Degree

Xiaozhi Yuan, MD

First Name & Middle Initial & Last Name & Degree

Dan Zhou, MD

First Name & Middle Initial & Last Name & Degree

Ruina Yang, MD

First Name & Middle Initial & Last Name & Degree

Jing Ren, MD

First Name & Middle Initial & Last Name & Degree

Shuoguo Li, MD

First Name & Middle Initial & Last Name & Degree

Wei Wang, MD

First Name & Middle Initial & Last Name & Degree

Shiyuan Song, MD

First Name & Middle Initial & Last Name & Degree

Weijiao Yin, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22887465

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

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