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

Esophageal Neoplasms Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02319187
• Other study ID #: CH-GI-064
• Status: Recruiting
• Phase: Phase 3
• First received: December 9, 2014
• Last updated: July 30, 2015
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Huang, M.D.
• Phone: 8610-87788103
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• S1
S1 80mg to 120 mg per day on Days 1-14, every 21 days
• S-1
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
• irinotecan
irinotecan 160mg/m2 d1, every 14 days

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine	Changsha
China	Mongolia Chifeng Hospital	Chifeng	Inner Mongolia
China	Herbin Medical University Cancer Hospital	Herbin
China	Ordos Central Hospital	Ordos	Inner Mongolia
China	Hebei four Hospital	Shijiazhuang	Hebei
China	Shanxi Province Cancer Hospital	Taiyuan	Shanxi
China	Jiangsu Taizhou peoples Hospital	Taizhou	Jiangsu
China	Tongji Hospital, Tongji Medical College	Wuhan	Hubei
China	Qinghai Cancer Hosptal	Xining	Qinghai
China	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang	Henan
China	Henan Cancer Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		2	No
Secondary	Adverse Events		2 year	No
Secondary	overall survival		3 year	No
Secondary	response rate		1.5 year	No
Secondary	quality of life		2 year	No