Back to resultsDifferent Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer (PFCRTESC)
Primary Purpose
Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
2 cycles cisplatin-5-fluorouracil
4 cycles cisplatin-5-fluorouracil
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stage III Esophageal Squamous Cell Carcinoma focused on measuring Chemoradiotherapy, Esophageal Squamous Cancer, Cisplatin-5-fluorouracil
Eligibility 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.
Sites / Locations
- The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Two cycles PF-radiotherapy
Four cycles PF-radiotherapy
Arm Description
2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32. radiotherapy： 50Gy，2 Gy/d，5d/w.
4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88. radiotherapy： 50Gy，2 Gy/d，5d/w.
Outcomes
Primary Outcome Measures
overall survival, OS
Secondary Outcome Measures
progression-free survival,PFS
overall remission rate, ORR
serious adverse event,SAE
quality of life, Qol
pathologic complete response rate
disease control rate,DCR
Full Information
NCT ID
NCT02607540
First Posted
November 16, 2015
Last Updated
January 10, 2016
Sponsor
The First Affiliated Hospital of Henan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02607540
Brief Title
Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
Acronym
PFCRTESC
Official Title
Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2020 (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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A two-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.
The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 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.
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 two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma
Keywords
Chemoradiotherapy, Esophageal Squamous Cancer, Cisplatin-5-fluorouracil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Two cycles PF-radiotherapy
Arm Type
Experimental
Arm Description
2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.
radiotherapy： 50Gy，2 Gy/d，5d/w.
Arm Title
Four cycles PF-radiotherapy
Arm Type
Active Comparator
Arm Description
4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.
radiotherapy： 50Gy，2 Gy/d，5d/w.
Intervention Type
Other
Intervention Name(s)
2 cycles cisplatin-5-fluorouracil
Other Intervention Name(s)
PF 2 cycles
Intervention Description
2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.
Intervention Type
Other
Intervention Name(s)
4 cycles cisplatin-5-fluorouracil
Other Intervention Name(s)
PF 4 cycles
Intervention Description
4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Radiation Therapy
Intervention Description
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
overall survival, OS
Time Frame
2 years
Secondary Outcome Measure Information:
Title
progression-free survival,PFS
Time Frame
2 years
Title
overall remission rate, ORR
Time Frame
16 weeks
Title
serious adverse event,SAE
Time Frame
16 weeks
Title
quality of life, Qol
Time Frame
16 weeks
Title
pathologic complete response rate
Time Frame
16 weeks
Title
disease control rate,DCR
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shegan Gao, Doctor
Phone
18638859977
Email
gsg112258@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tanyou Shan, Master
Phone
18537976669
Email
shantanyou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shegan Gao, Doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tanyou Shan, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiaoshan Feng, Doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jiachun Sun, Doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinshuai Wang, Doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guoqiang Kong, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaozhi Yuan, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruinuo Jia, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Zhou, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Ren, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruina Yang, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Wang, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongxuan Liu, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Wang, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shiyuan Song, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weijiao Yin, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yali Zhang, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital 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, doctor
Phone
0379 64811906
Email
gsg112258@163.com
First Name & Middle Initial & Last Name & Degree
tanyou shan, master
Phone
0379 64815350
Email
shantanyou@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
20888705
Citation
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Results Reference
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PubMed Identifier
11870157
Citation
Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.
Results Reference
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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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Results Reference
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PubMed Identifier
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Citation
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Citation
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Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
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