Clinical trial NCT02319187: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Neoplasms
Keywords: Esophageal Neoplasms
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-12-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression free survival
timeFrame: 2
Secondary outcomes:
measure: Adverse Events
timeFrame: 2 year
measure: overall survival
timeFrame: 3 year
measure: response rate
timeFrame: 1.5 year
measure: quality of life
timeFrame: 2 year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei four Hospital
state: Hebei
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College
state: Hubei
city: Chifeng
country: China
facility: Mongolia Chifeng Hospital
state: Inner Mongolia
city: Ordos
country: China
facility: Ordos Central Hospital
state: Inner Mongolia
city: Taizhou
country: China
facility: Jiangsu Taizhou peoples Hospital
state: Jiangsu
city: Xining
country: China
facility: Qinghai Cancer Hosptal
state: Qinghai
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
state: Shanxi
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Changsha
country: China
facility: Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine
city: Herbin
country: China
facility: Herbin Medical University Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe Xu, M.D.
role: STUDY_CHAIR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jing Huang
role: STUDY_CHAIR
References:
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.