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

July 2, 2016 updated by: The First Affiliated Hospital of Henan University of Science and Technology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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-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 Names:
  • 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 Names:
  • Aiheng
Radiation: Radiotherapy
concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Other Names:
  • 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 Names:
  • 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 Names:
  • Aiheng
Radiation: Radiotherapy
concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Other Names:
  • Radiation Therapy

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
overall remission rate, ORR
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
progression-free survival,PFS
Time Frame: 2 years
2 years
disease control rate,DCR
Time Frame: 16 weeks
16 weeks
serious adverse event，SAE
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Collaborators

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

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: Ruinuo Jia, 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
  • Principal Investigator: Dan Zhou, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • capecitabine-oxaliplatin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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