Clinical trial NCT02607540: Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
Official title: Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil 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
Cisplatin-5-fluorouracil
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 210
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A two-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.

The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 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: 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 two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

Eligibility criteria: Inclusion Criteria:

* age 45-75years 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: overall survival, OS
timeFrame: 2 years
Secondary outcomes:
measure: progression-free survival,PFS
timeFrame: 2 years
measure: overall remission rate, ORR
timeFrame: 16 weeks
measure: serious adverse event,SAE
timeFrame: 16 weeks
measure: quality of life, Qol
timeFrame: 16 weeks
measure: pathologic complete response rate
timeFrame: 16 weeks
measure: disease control rate,DCR
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, Doctor
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Tanyou Shan, Master
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaoshan Feng, Doctor
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jiachun Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xinshuai Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Guoqiang Kong, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaozhi Yuan, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Ruinuo Jia, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Dan Zhou, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jing Ren, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Ruina Yang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Wei Wang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Yongxuan Liu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Dan Wang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Shiyuan Song, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Weijiao Yin, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Yali Zhang, Master
role: PRINCIPAL_INVESTIGATOR
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