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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

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.


Condition or disease Intervention/treatment Phase
Stage III Esophageal Squamous Cell Carcinoma Esophageal Neoplasms Drug: Capecitabine(Aibin) Drug: Oxaliplatin(Aiheng) Radiation: Radiotherapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. overall survival, OS [ Time Frame: 2 years ]

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


Information from the National Library of Medicine

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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:

  • 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.

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): NCT02604615


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
The First Affiliated Hospital of Zhengzhou University
Xinyang Central Hospital
Anyang Tumor Hospital
No. 150 Central Hospital of the Chinese People Liberation Army
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
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

Publications:

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Responsible Party: The First Affiliated Hospital of Henan University of Science and Technology
ClinicalTrials.gov Identifier: NCT02604615     History of Changes
Other Study ID Numbers: capecitabine-oxaliplatin
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology:
Chemoradiotherapy
Esophageal Squamous Cancer
Capecitabine and oxaliplatin
Chinese
Randomized Controlled Trials
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents