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Spots Global Cancer Trial Database for The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy

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Trial Identification

Brief Title: The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy

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 ID: NCT02604615

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.

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China

Contact Details

Name: Shegan Gao, Doctor

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: STUDY_CHAIR

Name: Tanyou Shan, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: STUDY_DIRECTOR

Name: Xiaoshan Feng, Doctor

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: STUDY_DIRECTOR

Name: Jiachun Sun, Doctor

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Xinshuai Wang, Doctor

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Guoqiang Kong, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Xiaozhi Yuan, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: STUDY_DIRECTOR

Name: Ruinuo Jia, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Dan Zhou, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Jing Ren, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Ruina Yang, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Dan Wang, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Yongxuan Liu, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Yali Zhang, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Weijiao Yin, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Wei Wang, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Name: Shiyuan Song, Master

Affiliation: The First Affiliated Hospital of Henan University of Science and Technology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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