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Esophageal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

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.

capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total

Capecitabine(Aibin)

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.

Oxaliplatin(Aiheng)

concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity

Radiotherapy

Shegan Gao, Doctor

Tanyou Shan, Master

shegan gao, doctor

tanyou shan, master

Xiaoshan Feng, Doctor

Jiachun Sun, Doctor

Xinshuai Wang, Doctor

Guoqiang Kong, Master

Xiaozhi Yuan, Master

Ruinuo Jia, Master

Dan Zhou, Master

Jing Ren, Master

Ruina Yang, Master

Dan Wang, Master

Yongxuan Liu, Master

Yali Zhang, Master

Weijiao Yin, Master

Wei Wang, Master

Shiyuan Song, Master

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.

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.

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

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

The First Affiliated Hospital of Zhengzhou University

Xinyang Central Hospital

Anyang Tumor Hospital

No. 150 Central Hospital of the Chinese People Liberation Army

The First Affiliated Hospital of Henan University of Science and Technology

Fluorouracil

Cisplatin

oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Shegan Gao, M.D Ph.D

Tanyou Shan, M.D M.S

Xiaoshan Feng, M.D Ph.D

Jiachun Sun, M.D Ph.D

Xinshuai Wang, M.D Ph.D

Guoqiang Kong, M.D M.S

Xiaozhi Yuan, M.D M.S

Ruinuo Jia, M.D Ph.D

Dan Zhou, M.D M.S

Jing Ren, M.D M.S

Ruina Yang, M.D M.S

Dan Wang, M.D M.S

Wei Wang, M.D M.S

Yali Zhang, M.D M.S

Yongxuan Liu, M.D M.S

Weijiao Yin, M.D M.S

Shiyuan Song, M.D M.S

Guobao Zheng, M.D Ph.D

Daoke Yang, M.D M.S

Jianhua Wang, M.D Ph.D

Fuyou Zhou, M.D Ph.D

Nengchao Wang, M.D M.S

Anping Zheng, M.D M.S

Zhanhui Miao, M.D M.S

Ruiwen Zhang, M.D M.S

A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical.

The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.

Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer

Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy	NCT02604615	Stage III Esoph... Esophageal Neop...	Capecitabine(Ai... Oxaliplatin(Aih... Radiotherapy	45 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology
Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer	NCT02025036	Stage III Esoph... Stage II Esopha...	Capecitabine(Ai... Oxaliplatin(Aih... Radiotherapy	18 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology
The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy	NCT02604615	Stage III Esoph... Esophageal Neop...	Capecitabine(Ai... Oxaliplatin(Aih... Radiotherapy	45 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology
Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer	NCT02025036	Stage III Esoph... Stage II Esopha...	Capecitabine(Ai... Oxaliplatin(Aih... Radiotherapy	18 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology

Spots Global Cancer Trial Database for oxaliplatin(aiheng)