UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016954
Receipt No. R000019678
Scientific Title A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Date of disclosure of the study information 2015/04/01
Last modified on 2018/10/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Acronym A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Scientific Title A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Scientific Title:Acronym A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the relapse-free survival in the S-588410 group with the placebo group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Relapse free survival
Key secondary outcomes Specific CTL measurement, overall survival, disease-free survival, tumor evaluation, quality of life, assessment of AEs (CTCAE)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-588410 will be injected subcutaneously once weekly for 12 weeks and once every 2 weeks thereafter for 94 weeks.
Interventions/Control_2 Placebo will be injected subcutaneously once weekly for 12 weeks and once every 2 weeks thereafter for 94 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with thoracic esophageal squamous cell carcinoma after neoadjuvant therapy followed by curative resection.
2. Patients with lymph node metastasis positive histologically
3. HLA-A*24:02-positive patients
4. Patients who are male or female aged 20 years or older at the time of informed consent.
5. Patients with the ECOG PS 0 or 1 at enrollment.
6. Patients who provide a personally signed and dated informed consent document for participation in the study.
Key exclusion criteria 1. Patients who are expected to require anti-malignant tumor drug between enrollment and completion or discontinuation of the post-treatment period.
2. Patients with uncontrolled systemic or active infection.
Target sample size 270

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinobu Iwasaki
Organization Shionogi & Co., Ltd.
Division name Global Development Division
Zip code
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL 06-6209-7885
Email umin_s-588410@shionogi.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Kyokawa
Organization Shionogi & Co., Ltd.
Division name Corporate Communications Department
Zip code
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL 06-6209-7885
Homepage URL
Email umin_s-588410@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 27 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.