Clinical trial NCT02025036: Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer
Official title: Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stage III Esophageal Squamous Cell Carcinoma
Stage II Esophageal Squamous Cell Carcinoma
Keywords: Chemoradiotherapy， Esophageal Squamous Cancer
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Luoyang Central Hospital
name: Military 150 Hospital
name: Anyang Cancer Hospital
name: Nanyang Central Hospital
name: Henan Oncology Hospital
name: The First Affiliated Hospital of Xinyang Medical College
name: Sanmenxia Central Hospital
First posted: 2013-12-31
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age 18-75years old
* Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
* The patients have not received the surgery or chemo-radiotherapy.
* Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
* ALT、AST≤2.5\*N,Cr≤1.5\*N.
* performance status score 0-2

Exclusion Criteria:

* pregnant, lactating women
* Oxaliplatin or fluorouracil Allergy or metabolic disorders
* Radiotherapy contraindications
* History of organ transplantation
* Brain metastasis
* The peripheral nervous system disorders
* Severe infection
* Oral capecitabine who have difficulty with,such as 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.

Primary outcomes:
measure: Grade 3/5 acute toxicities
timeFrame: 90 days
measure: OS-2 year
timeFrame: 2 years
Secondary outcomes:
measure: PFS-2 year
timeFrame: 2 years
measure: overall remission rate, ORR
timeFrame: 16 weeks
measure: quality of life, Qol
timeFrame: 16 weeks
measure: pathologic complete response rate
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Shegan Gao, M.D Ph.D
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Tanyou Shan, M.D M.S
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaoshan Feng, M.D Ph.D
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jiachun Sun, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xinshuai Wang, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Guoqiang Kong, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaozhi Yuan, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Ruinuo Jia, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Dan Zhou, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jing Ren, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Ruina Yang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Dan Wang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Wei Wang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Yali Zhang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Yongxuan Liu, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Weijiao Yin, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Shiyuan Song, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: No. 150 Central Hospital of the Chinese People Liberation Army
name: Guobao Zheng, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Daoke Yang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Tumor Hospital
name: Jianhua Wang, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Anyang Tumour Hospital of Henan province
name: Fuyou Zhou, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Anyang Tumour Hospital of Henan province
name: Nengchao Wang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Anyang Tumour Hospital of Henan province
name: Anping Zheng, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Xinxiang Medical University, Henan province
name: Zhanhui Miao, M.D M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinxiang Central Hospital of Henan province
name: Ruiwen Zhang, M.D M.S
role: PRINCIPAL_INVESTIGATOR
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