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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025036
Recruitment Status : Unknown
Verified April 2020 by The First Affiliated Hospital of Henan University of Science and Technology.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2013
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
Luoyang Central Hospital
Military 150 Hospital
Anyang Cancer Hospital
Nanyang Central Hospital
Henan Oncology Hospital
The First Affiliated Hospital of Xinyang Medical College
Sanmenxia Central Hospital
Information provided by (Responsible Party):
The First Affiliated Hospital of Henan University of Science and Technology

Brief Summary:

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 630 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.


Condition or disease Intervention/treatment Phase
Stage III Esophageal Squamous Cell Carcinoma Stage II Esophageal Squamous Cell Carcinoma Drug: Capecitabine(Aibin) Drug: Oxaliplatin(Aiheng) Radiation: Radiotherapy Phase 3

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 overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer
Actual Study Start Date : October 2014
Estimated Primary Completion Date : April 25, 2022
Estimated Study Completion Date : April 25, 2022

Resource links provided by the National Library of Medicine


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 Name: Aibin

Drug: Oxaliplatin(Aiheng)
Oxaliplatin(Aiheng):65mg/m2,d1,8, 22, 29,I.V.
Other Name: Aiheng

Radiation: Radiotherapy
concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Other Name: 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 Name: 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 Name: Aibin

Radiation: Radiotherapy
concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Other Name: Radiation Therapy




Primary Outcome Measures :
  1. Grade 3/4 acute toxicities [ Time Frame: 90 days ]
    Grade 3/4 acute toxicities occurred during or within 90 days after RT

  2. PFS-2 year [ Time Frame: 2 years ]
    Progression Free Survival rate in 2 year from Randomization


Secondary Outcome Measures :
  1. OS-2 year [ Time Frame: 2 years ]
    Overall Survival rate in 2 year from Randomization

  2. overall remission rate, ORR [ Time Frame: 16 weeks ]
    overall remission rate after CRT

  3. quality of life, Qol [ Time Frame: 16 weeks ]
    quality of life evaluation

  4. pathologic complete response rate [ Time Frame: 16 weeks ]
    pathologic complete response rate confirmed by gastroscope biopsy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025036


Locations
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China, Henan
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Sponsors and Collaborators
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang Central Hospital
Military 150 Hospital
Anyang Cancer Hospital
Nanyang Central Hospital
Henan Oncology Hospital
The First Affiliated Hospital of Xinyang Medical College
Sanmenxia Central Hospital
Investigators
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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: Ruinuo Jia, 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
Publications:

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Responsible Party: The First Affiliated Hospital of Henan University of Science and Technology
ClinicalTrials.gov Identifier: NCT02025036    
Other Study ID Numbers: FirstHenanUST
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology:
Chemoradiotherapy, Esophageal Squamous Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents