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

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ClinicalTrials.gov Identifier: NCT02604615
Recruitment Status : Recruiting
First Posted : November 13, 2015
Last Update Posted : July 6, 2016
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
Xinyang Central Hospital
Anyang Tumor Hospital
No. 150 Central Hospital of the Chinese People Liberation Army
Information provided by (Responsible Party):
The First Affiliated Hospital of Henan University of Science and Technology

Tracking Information
First Submitted Date  ICMJE November 11, 2015
First Posted Date  ICMJE November 13, 2015
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2015)
overall survival, OS [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02604615 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2016)
  • progression-free survival,PFS [ Time Frame: 2 years ]
  • overall remission rate, ORR [ Time Frame: 16 weeks ]
  • serious adverse event,SAE [ Time Frame: 16 weeks ]
  • quality of life, Qol [ Time Frame: 16 weeks ]
  • pathologic complete response rate [ Time Frame: 16 weeks ]
  • disease control rate,DCR [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2015)
  • progression-free survival,PFS [ Time Frame: 2 years ]
  • overall remission rate, ORR [ Time Frame: 16 weeks ]
  • serious adverse event,SAE [ Time Frame: 16 weeks ]
  • quality of life, Qol [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage III Esophageal Squamous Cell Carcinoma
  • Esophageal Neoplasms
Intervention  ICMJE
  • Drug: Capecitabine(Aibin)
    capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total
    Other Name: Aibin
  • Drug: Oxaliplatin(Aiheng)
    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.
    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
Study Arms  ICMJE
  • Experimental: Capecitabine-oxaliplatin 2 cycles
    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.
    Interventions:
    • Drug: Capecitabine(Aibin)
    • Drug: Oxaliplatin(Aiheng)
    • Radiation: Radiotherapy
  • Active Comparator: Capecitabine-oxaliplatin 4 cycles
    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.
    Interventions:
    • Drug: Capecitabine(Aibin)
    • Drug: Oxaliplatin(Aiheng)
    • Radiation: Radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2015)
210
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shegan Gao, Doctor 18638859977 gsg112258@163.com
Contact: Tanyou Shan, Master 18537976669 shantanyou@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02604615
Other Study ID Numbers  ICMJE capecitabine-oxaliplatin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The First Affiliated Hospital of Henan University of Science and Technology
Study Sponsor  ICMJE The First Affiliated Hospital of Henan University of Science and Technology
Collaborators  ICMJE
  • The First Affiliated Hospital of Zhengzhou University
  • Xinyang Central Hospital
  • Anyang Tumor Hospital
  • No. 150 Central Hospital of the Chinese People Liberation Army
Investigators  ICMJE
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
Study Director: 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 Zhou, 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: Dan Wang, 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: Yali Zhang, 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: Wei Wang, 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
PRS Account The First Affiliated Hospital of Henan University of Science and Technology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP