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Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy (DCECRT)

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: NCT02603159
Recruitment Status : Unknown
Verified October 2015 by The First Affiliated Hospital of Henan University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Henan University of Science and Technology

Brief Summary:

Definitive chemoradiotherapy with cisplatin 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, Capecitabine is widely used in the chemotherapy of esophageal cancer.

The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.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) Radiation: radiotherapy Phase 3

Detailed Description:
We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine-5 weeks-radiotherapy
Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy: 50Gy ,2 Gy/d,5d/w.
Drug: Capecitabine(Aibin)
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 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

Active Comparator: Capecitabine-10 weeks-radiotherapy
Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy: 50Gy ,2 Gy/d,5d/w.
Drug: Capecitabine(Aibin)
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 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. overall survival, OS [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years ]
  2. overall remission rate, ORR [ Time Frame: 16 weeks ]
  3. serious adverse event [ Time Frame: 16 weeks ]
  4. quality of life, Qol [ Time Frame: 16 weeks ]
  5. pathologic complete response rate [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 45-75years 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): NCT02603159


Contacts
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Contact: Shegan Gao, Doctor 18638859977 gsg112258@163.com
Contact: Tanyou Shan, Master 18537976669 shantanyou@163.com

Locations
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China, Henan
The First Affiliated Hospital of Henan University of Science and Technology Recruiting
Luoyang, Henan, China, 471003
Contact: shegan gao, doctor    0379 64811906    gsg112258@163.com   
Contact: tanyou shan, master    0379 64815350    shantanyou@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Henan University of Science and Technology
Investigators
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Study Chair: Shegan Gao, Doctor The First Affiliated Hospital of Henan University of Science and Technology
Study Director: Tanyou Shan, Master The First Affiliated Hospital of Henan University of Science and Technology
Study Director: Xiaoshan Feng, Doctor The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Jiachun Sun, Doctor The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Xinshuai Wang, Doctor The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Guoqiang Kong, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Xiaozhi Yuan, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Ruinuo Jia, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Dan Zhuo, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Jing Ren, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Ruina Yang, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Yali Zhang, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Yongxuan Liu, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Wei Wang, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Dan Wang, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Weijiao Yin, Master The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Shiyuan Song, Master The First Affiliated Hospital of Henan University of Science and Technology
Publications:
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Responsible Party: The First Affiliated Hospital of Henan University of Science and Technology
ClinicalTrials.gov Identifier: NCT02603159    
Other Study ID Numbers: Capecitabine and esophageal
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: October 2015
Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology:
Chemoradiotherapy
Esophageal Squamous Cancer
Capecitabine
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents