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The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy (DCOECRT)

Primary Purpose

Stage III Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Capecitabine(Aibin)
Oxaliplatin(Aiheng)
Radiotherapy
Sponsored by
The First Affiliated Hospital of Henan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Esophageal Squamous Cell Carcinoma focused on measuring Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine and oxaliplatin, Chinese, Randomized Controlled Trials

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Voluntary participation and signed a consent form
  • Histologically proven squamous cell carcinoma of the esophagus, initial treatment (Not had surgery, radiotherapy, chemotherapy or targeted therapy)
  • the tumor was in T2-4N0-2M0, locally advanced(AJCC2002)
  • Have a measurable lesions.
  • Male or female who has fertility is willing to take contraceptive measures in the experiment
  • WBC≥3x10 9/L;Hb≥80g/L;ANC ≥1.5x10 9/L;PLT ≥100x10 9/L;TBIL< 1.5xN;AST (SGOT)/ALT (SGPT) ≤2.5xN;Cr≤1.5xN.
  • Performance status score 0-2
  • Expected lifetime>3 months

Exclusion Criteria:

  • Pregnant, lactating women or With fertility but did not use contraceptive measures
  • Has a history of severe allergic or idiosyncrasy
  • Hab been treated with surgery, radiation and chemotherapy or targeted therapy for esophageal cancer
  • After exploratory thoracotomy or Laying an esophageal tracheal stent
  • Received a major surgery treatment within 28 days prior to the start of research and treatment
  • History of organ transplantation
  • Has uncontrolled seizures or Lose self-knowledge because of mental illness
  • Severe infection
  • Oral capecitabine who have difficulty with,such as esophageal obstructed completely, 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

Capecitabine-oxaliplatin 2 cycles

Capecitabine-oxaliplatin 4 cycles

Arm Description

oxaliplatin:65mg/m2,d1,8,22,29,I.V; capecitabine: 625mg/m2, bid d1-5; q1w, po,5 weeks in total; radiotherapy:50Gy,2 Gy/d,5d/w.

oxaliplatin:65mg/m2,d1,8,22, 29,43,50,64,71,I.V; capecitabine:625mg/m2,bid d1-5; q1w, po,10 weeks in total; 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

First Posted
November 11, 2015
Last Updated
July 2, 2016
Sponsor
The First Affiliated Hospital of Henan University of Science and Technology
Collaborators
The First Affiliated Hospital of Zhengzhou University, Xinyang Central Hospital, Anyang Tumor Hospital, No. 150 Central Hospital of the Chinese People Liberation Army
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1. Study Identification

Unique Protocol Identification Number
NCT02604615
Brief Title
The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy
Acronym
DCOECRT
Official Title
Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 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
Collaborators
The First Affiliated Hospital of Zhengzhou University, Xinyang Central Hospital, Anyang Tumor Hospital, No. 150 Central Hospital of the Chinese People Liberation Army

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive chemoradiotherapy is the standard regimen in Western countries for patients with esophageal cancer who can't receive surgery or reject surgery. But in China because of its severer toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to its characristic of low toxic reaction. The purpose of this study is to confirm the efficacy and safety of the different cycles(two cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma radical concurrent chemoradiotherapy. A total of 60 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
First: The investigators use excel generate a 5 digits random number table. After subjects sign the informed consent, investigators will chose one for themm. Subject who get an odd number will receive 2cycles' chemotheapy concurrent radiotherapy and even number receive 4cycles'. Investigators should record the congruent relationship of subjects with group code. Second: The investigators are required to record subjects' base measurements. The base measurements items:1.Tumor confirmed date,TNM staging,History of esophageal cancer treatment;2.Demographic data,past medical history;3.physical examination(a detailed system check including general neurological examination);4.vital signs,Height,Weight;5.PS score,Quality of life;6.serum biochemistry(ALT,AST,AKP,TBIL,blood glucose,BUN,Ccr,electrolyte,et al.);7. Blood RT(RBC,HGB,WBC,ANC,PLT,et al.);8.Urine routines;9.Endoscopic biopsy(More than 3 pieces of biopsy specimens),chest CT,abdomen ultrasound/CT/MRI,PET-CT,et al.;10.Blood/urine pregnancy tests;11.Collect blood samples(5 ml);12.Preserve CorpseSample. note:Check the time limit-2 weeks before get into groups. Third:Observation items during treatment include 3-8 items of the base measurements;Radiotherapy 20 times, should review of esophageal barium meal or chest CT. The investigators need to observe adverse event during treatment and eveluate the relationship of adverse event with researched therapeutic regimen according to the Common Terminology Criteria for Adverse Events,CTCAE) (V4.0, 2009-05-28) and accurately fill in Case Report Form(CRF). Fourth: Follow-up items include 3-9 items of the base measurements;bood and tissue sample should also be preserved when subject receives 16th weeks' review. The patient who withdrew from the study during researched treatment must accept the end evaluation research. The investigators must record the reason and the date of termination in patient' progress note and CRF. Cases of complete report should transfer to data administrators after investigates by clinical research associate. Data administrators input and management data.

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, Esophageal Neoplasms
Keywords
Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine and oxaliplatin, Chinese, Randomized Controlled Trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine-oxaliplatin 2 cycles
Arm Type
Experimental
Arm Description
oxaliplatin:65mg/m2,d1,8,22,29,I.V; capecitabine: 625mg/m2, bid d1-5; q1w, po,5 weeks in total; radiotherapy:50Gy,2 Gy/d,5d/w.
Arm Title
Capecitabine-oxaliplatin 4 cycles
Arm Type
Active Comparator
Arm Description
oxaliplatin:65mg/m2,d1,8,22, 29,43,50,64,71,I.V; capecitabine:625mg/m2,bid d1-5; q1w, po,10 weeks in total; radiotherapy:50Gy ,2 Gy/d,5d/w.
Intervention Type
Drug
Intervention Name(s)
Capecitabine(Aibin)
Other Intervention Name(s)
Aibin
Intervention Description
capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin(Aiheng)
Other Intervention Name(s)
Aiheng
Intervention Description
Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,I.V. or Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,43,50,64,71,I.V.
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: Voluntary participation and signed a consent form Histologically proven squamous cell carcinoma of the esophagus, initial treatment (Not had surgery, radiotherapy, chemotherapy or targeted therapy) the tumor was in T2-4N0-2M0, locally advanced(AJCC2002) Have a measurable lesions. Male or female who has fertility is willing to take contraceptive measures in the experiment WBC≥3x10 9/L;Hb≥80g/L;ANC ≥1.5x10 9/L;PLT ≥100x10 9/L;TBIL< 1.5xN;AST (SGOT)/ALT (SGPT) ≤2.5xN;Cr≤1.5xN. Performance status score 0-2 Expected lifetime>3 months Exclusion Criteria: Pregnant, lactating women or With fertility but did not use contraceptive measures Has a history of severe allergic or idiosyncrasy Hab been treated with surgery, radiation and chemotherapy or targeted therapy for esophageal cancer After exploratory thoracotomy or Laying an esophageal tracheal stent Received a major surgery treatment within 28 days prior to the start of research and treatment History of organ transplantation Has uncontrolled seizures or Lose self-knowledge because of mental illness Severe infection Oral capecitabine who have difficulty with,such as esophageal obstructed completely, 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
Study Director
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
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
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
Yali Zhang, 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
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
Shiyuan Song, 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

Plan to Share IPD
Undecided
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20888705
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The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy

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