Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial
NCT ID: NCT02319187
Last Updated: 2015-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2014-12-31
2017-06-30
Brief Summary
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The purpose of this study is to evaluate the progression free survival and safety of irinotecan plus S1 versus S1 alone in the patients with previously treated advanced esophageal cancer
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
S1
S1
S1 80mg to 120 mg per day on Days 1-14, every 21 days
Arm B
S1 and irinotecan
S-1
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
irinotecan
irinotecan 160mg/m2 d1, every 14 days
Interventions
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S1
S1 80mg to 120 mg per day on Days 1-14, every 21 days
S-1
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
irinotecan
irinotecan 160mg/m2 d1, every 14 days
Eligibility Criteria
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Inclusion Criteria
* 18 ≤ age ≤ 70;
* ECOG 0-2;
* Previously Treated with platinum or paclitaxel based regimen;
* Uni-dimensionally measurable disease (CT or MRI as per RECIST);
* Patients should have a projected life expectancy of at least 3 months;
* Completion of baseline quality of life questionnaire
* Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
* Written informed consent
Exclusion Criteria
* adjuvant chemotherapy with 5-FU-based chemotherapy within 6 months prior to the start of study treatment;
* Active infection requiring antibiotics
* Pregnant, lactating women
* Psychiatric illness, epileptic disorders
* Concurrent systemic illness not appropriate for chemotherapy
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jing Huang
Professor
Principal Investigators
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Binghe Xu, M.D.
Role: STUDY_CHAIR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jing Huang
Role: STUDY_CHAIR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Hebei four Hospital
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College
Wuhan, Hubei, China
Mongolia Chifeng Hospital
Chifeng, Inner Mongolia, China
Ordos Central Hospital
Ordos, Inner Mongolia, China
Jiangsu Taizhou peoples Hospital
Taizhou, Jiangsu, China
Qinghai Cancer Hosptal
Xining, Qinghai, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine
Changsha, , China
Herbin Medical University Cancer Hospital
Herbin, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Jing Huang, M.D.
Role: CONTACT
Facility Contacts
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Da Jiang, MD
Role: primary
Ping Lu, MD
Role: primary
Qingxia Fan, MD
Role: primary
Xianglin Yuan, MD.,Ph.D
Role: primary
Changwu Ma
Role: primary
Gaowa Jin, MD
Role: primary
Junxing Huang, MD
Role: primary
Chengmao Zhao, MD
Role: primary
Guangcheng Hu, MD
Role: primary
Xi Wang, M.D
Role: primary
Lin Wu, MD
Role: primary
Yuxian Bai, MD
Role: primary
Ying Liu, MD
Role: primary
References
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Huang J, Xu B, Liu Y, Huang J, Lu P, Ba Y, Wu L, Bai Y, Zhang S, Feng J, Cheng Y, Li J, Wen L, Yuan X, Ma C, Hu C, Fan Q, Wang X. Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, multicenter, open-labeled phase 3 trial. Cancer Commun (Lond). 2019 Apr 2;39(1):16. doi: 10.1186/s40880-019-0359-7.
Other Identifiers
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CH-GI-064
Identifier Type: -
Identifier Source: org_study_id
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