Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer (CRTCOESC)

February 3, 2023 updated by: The First Affiliated Hospital of Henan University of Science and Technology

Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer

A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical.

The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-75years old
  • Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
  • The patients have not received the surgery or chemo-radiotherapy.
  • Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
  • ALT、AST≤2.5*N,Cr≤1.5*N.
  • performance status score 0-2

Exclusion Criteria:

  • pregnant, lactating women
  • Oxaliplatin or fluorouracil Allergy or metabolic disorders
  • Radiotherapy contraindications
  • History of organ transplantation
  • Brain metastasis
  • The peripheral nervous system disorders
  • Severe infection
  • Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
  • Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
  • Other malignant tumor in recent 5 years.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capecitabine-oxaliplatin-radiotherapy

oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
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
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
  • Radiation Therapy
ACTIVE_COMPARATOR: cisplatin with 5-FU and radiotherapy

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.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
  • Radiation Therapy
EXPERIMENTAL: Capecitabine and radiotherapy
capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
Drug: Capecitabine(Aibin)
capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
Other Names:
  • Aibin
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
  • Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS-2 year
Time Frame: 2 years
Overall Survival rate in 2 year from Randomization
2 years
Grade 3/5 acute toxicities
Time Frame: 90 days
Grade 3/5 acute toxicities occurred during or within 90 days after RT
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS-2 year
Time Frame: 2 years
Progression Free Survival rate in 2 year from Randomization
2 years
overall remission rate, ORR
Time Frame: 16 weeks
overall remission rate after CRT
16 weeks
quality of life, Qol
Time Frame: 16 weeks
quality of life evaluation
16 weeks
pathologic complete response rate
Time Frame: 16 weeks
pathologic complete response rate confirmed by gastroscope biopsy
16 weeks

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

Luoyang Central Hospital
Nanyang Central Hospital
Sanmenxia Central Hospital
Military 150 Hospital
Anyang Cancer Hospital
Henan Oncology Hospital
The First Affiliated Hospital of Xinyang Medical College

Investigators

  • Study Chair: Shegan Gao, M.D Ph.D, The First Affiliated Hospital of Henan University of Science and Technology
  • Study Director: Tanyou Shan, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Study Director: Xiaoshan Feng, M.D Ph.D, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Jiachun Sun, M.D Ph.D, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Xinshuai Wang, M.D Ph.D, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Guoqiang Kong, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Xiaozhi Yuan, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Dan Zhou, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Jing Ren, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Ruina Yang, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Dan Wang, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Wei Wang, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Yali Zhang, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Yongxuan Liu, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Weijiao Yin, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Shiyuan Song, M.D M.S, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Guobao Zheng, M.D Ph.D, No. 150 Central Hospital of the Chinese People Liberation Army
  • Principal Investigator: Daoke Yang, M.D M.S, The First Affiliated Hospital of Zhengzhou University
  • Principal Investigator: Jianhua Wang, M.D Ph.D, Henan Tumor Hospital
  • Principal Investigator: Fuyou Zhou, M.D Ph.D, Anyang Tumour Hospital of Henan province
  • Principal Investigator: Nengchao Wang, M.D M.S, Anyang Tumour Hospital of Henan province
  • Principal Investigator: Anping Zheng, M.D M.S, Anyang Tumour Hospital of Henan province
  • Principal Investigator: Zhanhui Miao, M.D M.S, Affiliated Hospital of Xinxiang Medical University, Henan province
  • Principal Investigator: Ruiwen Zhang, M.D M.S, Xinxiang Central Hospital of Henan Province
  • Principal Investigator: Ruinuo Jia, M.D Ph.D, The First Affiliated Hospital 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 (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

September 13, 2022

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

November 17, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (ESTIMATE)

December 31, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstHenanUST

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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