- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02319187
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial
July 30, 2015 updated by: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Squamous Cell Carcinoma (ESWN 01 Trial): a Phase 3, Prospective,Multicenter, Randomised Study
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Two arms, phase 3 study of irinotecan plus S1 versus S1 alone in previously treated patients with recurrent or metastatic esophageal cancer.
240 Patients will be enrolled in this trial.
The primary objective of this study is to determine the PFS of the two arms.
One arm is as follows: irinotecan 160 mg/m2 will be administered as an intravenous infusion over 60 minutes on Days 1, followed by S1 80mg to 120 mg per day on Days 1-10, every 14 days per cycle.
The other arm is S1 80mg to 120 mg per day on Days 1-14, every 21 days per cycle.This study will also include the investigation of UGT1A1polymorphisms in the study population.
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Huang, M.D.
- Phone Number: 8610-87788103
Study Locations
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-
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Beijing, China, 100021
- Recruiting
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Principal Investigator:
- Jing Huang, M.D.
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Changsha, China
- Recruiting
- Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine
-
Contact:
- Lin Wu, MD
-
Principal Investigator:
- Lin Wu, MD
-
Herbin, China
- Recruiting
- Herbin Medical University Cancer Hospital
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Contact:
- Yuxian Bai, MD
-
Zhengzhou, China
- Recruiting
- Henan Cancer Hospital
-
Contact:
- Ying Liu, MD
-
Principal Investigator:
- Ying Liu, MD
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-
Hebei
-
Shijiazhuang, Hebei, China
- Recruiting
- Hebei four Hospital
-
-
Henan
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Xinxiang, Henan, China
- Recruiting
- The First Affiliated Hospital of Xinxiang Medical College
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Contact:
- Ping Lu, MD
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Zhengzhou, Henan, China
- Recruiting
- The first affiliated hospital of Zhengzhou University
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Contact:
- Qingxia Fan, MD
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-
Hubei
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Wuhan, Hubei, China
- Recruiting
- Tongji Hospital, Tongji Medical College
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Contact:
- Xianglin Yuan, MD.,Ph.D
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-
Inner Mongolia
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Chifeng, Inner Mongolia, China
- Recruiting
- Mongolia Chifeng Hospital
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Contact:
- Changwu Ma
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Ordos, Inner Mongolia, China
- Recruiting
- Ordos Central Hospital
-
Contact:
- Gaowa Jin, MD
-
-
Jiangsu
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Taizhou, Jiangsu, China
- Recruiting
- Jiangsu Taizhou peoples Hospital
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Contact:
- Junxing Huang, MD
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Qinghai
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Xining, Qinghai, China
- Recruiting
- Qinghai Cancer Hosptal
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Contact:
- Chengmao Zhao, MD
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Shanxi
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Taiyuan, Shanxi, China
- Recruiting
- Shanxi Province Cancer Hospital
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Contact:
- Guangcheng Hu, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically proven esophageal squamous cell carcinoma;
- 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:
- Previous chemotherapy with 5-FU or irinotecan after recurrence or metastasis;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm A
S1
|
S1 80mg to 120 mg per day on Days 1-14, every 21 days
|
EXPERIMENTAL: Arm B
S1 and irinotecan
|
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
irinotecan 160mg/m2 d1, every 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: 2
|
2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 3 year
|
3 year
|
Adverse Events
Time Frame: 2 year
|
2 year
|
response rate
Time Frame: 1.5 year
|
1.5 year
|
quality of life
Time Frame: 2 year
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
June 1, 2017
Study Registration Dates
First Submitted
December 9, 2014
First Submitted That Met QC Criteria
December 17, 2014
First Posted (ESTIMATE)
December 18, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
August 3, 2015
Last Update Submitted That Met QC Criteria
July 30, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- CH-GI-064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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