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Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

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ClinicalTrials.gov Identifier: NCT02319187
Recruitment Status : Unknown
Verified April 2015 by Jing Huang, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 18, 2014
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Jing Huang, Chinese Academy of Medical Sciences

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: S1 Drug: S-1 Drug: irinotecan Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A
S1
Drug: S1
S1 80mg to 120 mg per day on Days 1-14, every 21 days

Experimental: Arm B
S1 and irinotecan
Drug: S-1
S1 80mg to 120 mg per day on Days 1-10, every 14 days;

Drug: irinotecan
irinotecan 160mg/m2 d1, every 14 days




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2 ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 year ]
  2. overall survival [ Time Frame: 3 year ]
  3. response rate [ Time Frame: 1.5 year ]
  4. quality of life [ Time Frame: 2 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319187


Contacts
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Contact: Jing Huang, M.D. 8610-87788103

Locations
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China, Hebei
Hebei four Hospital Recruiting
Shijiazhuang, Hebei, China
Contact: Da Jiang, MD         
China, Henan
The First Affiliated Hospital of Xinxiang Medical College Recruiting
Xinxiang, Henan, China
Contact: Ping Lu, MD         
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Qingxia Fan, MD         
China, Hubei
Tongji Hospital, Tongji Medical College Recruiting
Wuhan, Hubei, China
Contact: Xianglin Yuan, MD.,Ph.D         
China, Inner Mongolia
Mongolia Chifeng Hospital Recruiting
Chifeng, Inner Mongolia, China
Contact: Changwu Ma         
Ordos Central Hospital Recruiting
Ordos, Inner Mongolia, China
Contact: Gaowa Jin, MD         
China, Jiangsu
Jiangsu Taizhou peoples Hospital Recruiting
Taizhou, Jiangsu, China
Contact: Junxing Huang, MD         
China, Qinghai
Qinghai Cancer Hosptal Recruiting
Xining, Qinghai, China
Contact: Chengmao Zhao, MD         
China, Shanxi
Shanxi Province Cancer Hospital Recruiting
Taiyuan, Shanxi, China
Contact: Guangcheng Hu, MD         
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Xi Wang, M.D         
Principal Investigator: Binghe Xu, M.D.         
Principal Investigator: Jing Huang, M.D.         
Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine Recruiting
Changsha, China
Contact: Lin Wu, MD         
Principal Investigator: Lin Wu, MD         
Herbin Medical University Cancer Hospital Recruiting
Herbin, China
Contact: Yuxian Bai, MD         
Principal Investigator: Yuxian Bai, MD         
Henan Cancer Hospital Recruiting
Zhengzhou, China
Contact: Ying Liu, MD         
Principal Investigator: Ying Liu, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Chair: Binghe Xu, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Chair: Jing Huang Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jing Huang, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02319187     History of Changes
Other Study ID Numbers: CH-GI-064
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: April 2015
Keywords provided by Jing Huang, Chinese Academy of Medical Sciences:
Esophageal Neoplasms
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents