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

Primary Purpose

Esophageal Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
S1
S-1
irinotecan
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophageal Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hebei four HospitalRecruiting
  • The First Affiliated Hospital of Xinxiang Medical CollegeRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Tongji Hospital, Tongji Medical CollegeRecruiting
  • Mongolia Chifeng HospitalRecruiting
  • Ordos Central HospitalRecruiting
  • Jiangsu Taizhou peoples HospitalRecruiting
  • Qinghai Cancer HosptalRecruiting
  • Shanxi Province Cancer HospitalRecruiting
  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
  • Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of MedicineRecruiting
  • Herbin Medical University Cancer HospitalRecruiting
  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

S1

S1 and irinotecan

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

Adverse Events
overall survival
response rate
quality of life

Full Information

First Posted
December 9, 2014
Last Updated
July 30, 2015
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02319187
Brief Title
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
Keywords
Esophageal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
S1
Arm Title
Arm B
Arm Type
Experimental
Arm Description
S1 and irinotecan
Intervention Type
Drug
Intervention Name(s)
S1
Intervention Description
S1 80mg to 120 mg per day on Days 1-14, every 21 days
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
irinotecan 160mg/m2 d1, every 14 days
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
2
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
2 year
Title
overall survival
Time Frame
3 year
Title
response rate
Time Frame
1.5 year
Title
quality of life
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, M.D.
Phone
8610-87788103
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jing Huang
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hebei four Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da Jiang, MD
Facility Name
The First Affiliated Hospital of Xinxiang Medical College
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Lu, MD
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxia Fan, MD
Facility Name
Tongji Hospital, Tongji Medical College
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianglin Yuan, MD.,Ph.D
Facility Name
Mongolia Chifeng Hospital
City
Chifeng
State/Province
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changwu Ma
Facility Name
Ordos Central Hospital
City
Ordos
State/Province
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaowa Jin, MD
Facility Name
Jiangsu Taizhou peoples Hospital
City
Taizhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junxing Huang, MD
Facility Name
Qinghai Cancer Hosptal
City
Xining
State/Province
Qinghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengmao Zhao, MD
Facility Name
Shanxi Province Cancer Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangcheng Hu, MD
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wang, M.D
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D.
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.
Facility Name
Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Wu, MD
First Name & Middle Initial & Last Name & Degree
Lin Wu, MD
Facility Name
Herbin Medical University Cancer Hospital
City
Herbin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxian Bai, MD
First Name & Middle Initial & Last Name & Degree
Yuxian Bai, MD
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Liu, MD
First Name & Middle Initial & Last Name & Degree
Ying Liu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30940189
Citation
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.
Results Reference
derived

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

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