Esophageal NeoplasmsPhase 3NCT02319187
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial
A Phase 3 study testing S1, S-1 and irinotecan in people with Esophageal Neoplasms, run by Chinese Academy of Medical Sciences at 13 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- S1, S-1 and irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 13 sitesChina
- Study dates
- Dec 2014to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
Jing Huang, M.D. contact
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Xi Wang, M.D
Binghe Xu, M.D.
- Recruiting
Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine
Changsha
Lin Wu, MD
Lin Wu, MD
- Recruiting
Mongolia Chifeng Hospital
Chifeng, Inner Mongolia
Changwu Ma
- Recruiting
Herbin Medical University Cancer Hospital
Herbin
Yuxian Bai, MD
Yuxian Bai, MD
- Recruiting
Ordos Central Hospital
Ordos, Inner Mongolia
Gaowa Jin, MD
- Recruiting
Hebei four Hospital
Shijiazhuang, Hebei
Da Jiang, MD
- Recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi
Guangcheng Hu, MD
- Recruiting
Jiangsu Taizhou peoples Hospital
Taizhou, Jiangsu
Junxing Huang, MD
- Recruiting
Tongji Hospital, Tongji Medical College
Wuhan, Hubei
Xianglin Yuan, MD.,Ph.D
- Recruiting
Qinghai Cancer Hosptal
Xining, Qinghai
Chengmao Zhao, MD
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan
Ping Lu, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Qingxia Fan, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou
Ying Liu, MD
Ying Liu, MD
About this study
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
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
Read the 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.
- Conditions
- Esophageal Neoplasms
- Being tested
- S1, S-1, irinotecan
- Keywords
- Esophageal Neoplasms
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1Drug
S1 80mg to 120 mg per day on Days 1-14, every 21 days
S-1Drug
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
irinotecanDrug
irinotecan 160mg/m2 d1, every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | S1 Receives: Drug: S1 |
| Arm B | Experimental | S1 and irinotecan Receives: Drug: S-1; Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 2
Secondary outcomes (4)
Adverse Events
Measured: 2 year
overall survival
Measured: 3 year
response rate
Measured: 1.5 year
quality of life
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Huang, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, M.D., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical SciencesJing Huang, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319187
- Sponsor's protocol ID
- CH-GI-064
- Status last verified
- Apr 2015
- First submitted
- 9 Dec 2014
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30940189
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02319187
- Acronym / sponsor ID
- CH-GI-064
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: S1S1 |
| Arm B | Experimental | Drug: S-1, Drug: irinotecanS1 and irinotecan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S1S1 80mg to 120 mg per day on Days 1-14, every 21 days | Drug | Arm A |
| S-1S1 80mg to 120 mg per day on Days 1-10, every 14 days; | Drug | Arm B |
| irinotecanirinotecan 160mg/m2 d1, every 14 days | Drug | Arm B |
Primary outcome
progression free survival
Time frame: 2
4 secondary outcomes
Adverse Events
Time frame: 2 year
overall survival
Time frame: 3 year
response rate
Time frame: 1.5 year
quality of life
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Derived from this study: PubMed 30940189Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Huang, M.D. contact
Binghe Xu, M.D. study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jing Huang study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S1, S-1 and irinotecan in people with Esophageal Neoplasms, run by Chinese Academy of Medical Sciences at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, M.D. (8610-87788103), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.