- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02603159
Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy (DCECRT)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Shegan Gao, Doctor
- Phone Number: 18638859977
- Email: gsg112258@163.com
Study Contact Backup
- Name: Tanyou Shan, Master
- Phone Number: 18537976669
- Email: shantanyou@163.com
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471003
- Recruiting
- The first affiliated hospital of Henan University of science and technology
-
Contact:
- shegan gao, doctor
- Phone Number: 0379 64811906
- Email: gsg112258@163.com
-
Contact:
- tanyou shan, master
- Phone Number: 0379 64815350
- Email: shantanyou@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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 |
---|---|
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.
|
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total
Other Names:
Concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Other Names:
|
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.
|
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total
Other Names:
Concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival, OS
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 2 years
|
2 years
|
overall remission rate, ORR
Time Frame: 16 weeks
|
16 weeks
|
serious adverse event
Time Frame: 16 weeks
|
16 weeks
|
quality of life, Qol
Time Frame: 16 weeks
|
16 weeks
|
pathologic complete response rate
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Investigators
- 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 and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- Capecitabine and esophageal
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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