NCT02319187

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

December 9, 2014

Last Update Submit

July 30, 2015

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2

Secondary Outcomes (4)

  • Adverse Events

    2 year

  • overall survival

    3 year

  • response rate

    1.5 year

  • quality of life

    2 year

Study Arms (2)

Arm A

ACTIVE COMPARATOR

S1

Drug: S1

Arm B

EXPERIMENTAL

S1 and irinotecan

Drug: S-1Drug: irinotecan

Interventions

S-1DRUG

S1 80mg to 120 mg per day on Days 1-10, every 14 days;

Arm B
irinotecanDRUG

irinotecan 160mg/m2 d1, every 14 days

Arm B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven esophageal squamous cell carcinoma;
  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hebei four Hospital

Shijiazhuang, Hebei, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital, Tongji Medical College

Wuhan, Hubei, China

RECRUITING

Mongolia Chifeng Hospital

Chifeng, Inner Mongolia, China

RECRUITING

Ordos Central Hospital

Ordos, Inner Mongolia, China

RECRUITING

Jiangsu Taizhou peoples Hospital

Taizhou, Jiangsu, China

RECRUITING

Qinghai Cancer Hosptal

Xining, Qinghai, China

RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine

Changsha, China

RECRUITING

Herbin Medical University Cancer Hospital

Herbin, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30940189DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination)Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Jing Huang, M.D.

CONTACT

8610-87788103

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 18, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

August 3, 2015

Record last verified: 2015-04

Locations

CN(13)