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

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

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

      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Jing Huang, M.D.
      • 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
        • Contact:
          • Yuxian Bai, MD
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Ying Liu, MD
        • Principal Investigator:
          • Ying Liu, MD
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei four Hospital
    • Henan
      • Xinxiang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
          • Ping Lu, MD
      • Zhengzhou, Henan, China
        • Recruiting
        • The first affiliated hospital of Zhengzhou University
        • Contact:
          • Qingxia Fan, MD
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College
        • Contact:
          • Xianglin Yuan, MD.,Ph.D
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China
        • Recruiting
        • Mongolia Chifeng Hospital
        • Contact:
          • Changwu Ma
      • Ordos, Inner Mongolia, China
        • Recruiting
        • Ordos Central Hospital
        • Contact:
          • Gaowa Jin, MD
    • Jiangsu
      • Taizhou, Jiangsu, China
        • Recruiting
        • Jiangsu Taizhou peoples Hospital
        • Contact:
          • Junxing Huang, MD
    • Qinghai
      • Xining, Qinghai, China
        • Recruiting
        • Qinghai Cancer Hosptal
        • Contact:
          • Chengmao Zhao, MD
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Province Cancer Hospital
        • Contact:
          • Guangcheng Hu, MD

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

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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