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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02319187

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

18.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Arm A

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

Outcome Measures

Primary Outcome Measures

progression free survival [2]

Secondary Outcome Measures

Adverse Events [2 year]
overall survival [3 year]
response rate [1.5 year]
quality of life [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hebei four Hospital	Shijiazhuang	Hebei	China
2	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang	Henan	China
3	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
4	Tongji Hospital, Tongji Medical College	Wuhan	Hubei	China
5	Mongolia Chifeng Hospital	Chifeng	Inner Mongolia	China
6	Ordos Central Hospital	Ordos	Inner Mongolia	China
7	Jiangsu Taizhou peoples Hospital	Taizhou	Jiangsu	China
8	Qinghai Cancer Hosptal	Xining	Qinghai	China
9	Shanxi Province Cancer Hospital	Taiyuan	Shanxi	China
10	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing		China	100021
11	Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine	Changsha		China
12	Herbin Medical University Cancer Hospital	Herbin		China
13	Henan Cancer Hospital	Zhengzhou		China

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jing Huang, Professor, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02319187

Other Study ID Numbers:

CH-GI-064

First Posted:

Dec 18, 2014

Last Update Posted:

Aug 3, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Jing Huang, Professor, Chinese Academy of Medical Sciences

Esophageal Neoplasms

Additional relevant MeSH terms:

Esophageal Neoplasms

Irinotecan

Study Results

No Results Posted as of Aug 3, 2015