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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02319187

Enrollment

240

Registered

2014-12-18

Start date

2014-12-31

Completion date

2017-06-30

Last updated

2015-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms

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.

Interventions

DRUGS1

S1 80mg to 120 mg per day on Days 1-14, every 21 days

DRUGS-1

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

DRUGirinotecan

irinotecan 160mg/m2 d1, every 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
progression free survival	2

Secondary

Measure	Time frame
Adverse Events	2 year
overall survival	3 year
response rate	1.5 year
quality of life	2 year

Countries

China

Contacts

Primary ContactJing Huang, M.D.

8610-87788103

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026