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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016830
Receipt No. R000019532
Scientific Title A phase II study of S-1 therapy for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Date of disclosure of the study information 2015/03/17
Last modified on 2019/07/20

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Basic information
Public title A phase II study of S-1 therapy for
advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Acronym A phase II study of S-1 therapy for
advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Scientific Title A phase II study of S-1 therapy for
advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Scientific Title:Acronym A phase II study of S-1 therapy for
advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Region
Japan

Condition
Condition Esophageal carcinoma
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of S-1 for advanced/recurrent esophageal carcinoma resistant/intolerable to 5-FU, platinum compounds, and Taxane.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease control rate (DCR)
Key secondary outcomes Overall survival
Progression free surviva(PFS)
Time to Treatment Failure(TTF)
Response rate(RR)
Incidence of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1: twice a day oral intake on days 1-28, followed by14 days rest.
Interventions/Control_2
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) histologically proven esophageal squamous cell carcinoma or esophageal adenosquamous carcinoma
2) advanced/recurrent esophageal cancer resistant /intolerable to fluoropyrimydine (exclude S-1), platinum compounds, or Taxane
3) without prior use of TS-1
4) with/withnot measurable lesions by RESIST ver. 1.1
5) 20 years of age or older
6) Performance Status by Eastern Cooperative Oncology Group of 0 or 1
7) with an expected survival period longer than 3 months from the registration
8) with a rest longer than 14 days from the end of prior therapy
9) with good functions of important organs tested within 14 days before registration
1. Neutrophil: =>1,500/mm3
2. Hemoglobin: =>8.0 g/dl
3. Platelet: =>100,000/mm3
4. T.bil.: =<1.5 mg/dL
5. AST, ALT: =< 100 IU/L
6. cleatinine clearance : =>50mL/min
10) with HBs antigen negative within 1 year, or under administration of anti-nuclear analogues by a specialist for liver diseases when HSs is positive
11) with written Informed Consent
Key exclusion criteria 1) with active double cancers excluding carcinoma in situ and/or prior cancer cured with shorter than 5 year interval period
2) with uncontrollable DM
3) with a history of cardiac infarction and/or anxiety angina pectoris within 6 months
4) with uncontrolled arrhythmia
5) under continuous steroids medication
6) with liver cirrhosis
7) with active infectious disease
8) with pericardial fluid, pleural fluid and/or ascites which needs drainage except controlled pleural fluid or ascites
9) have a history of Grade 2-4 hypersensitivity (CTCAE ver.4.0)
10) with grade 2-4 peripheral neuropathy by CTCAE v4.0
11) with blood transfusion within 2 weeks and/or continuous bleeding
12) with a figure of interstitial pneumonitis except radiation pneumonitis
13) with metastatic lesions in the central nerve
14) patient with psychological disorder who cannot participate in this study
15) women pregnant and/or nursing or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Ki
Organization Osaka Medical College
Division name chemotherapy center
Zip code
Address 2-7,Daigakutyou,Takatsuk,City,Osaka, 569-8686
TEL 072-683-1221
Email in2058@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Ki
Organization Osaka Medical College
Division name chemotherapy center
Zip code
Address 2-7,Daigakutyou,Takatsuk,City,Osaka, 569-8686
TEL 072-683-1221
Homepage URL
Email in2058@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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 大阪医科大学(大阪府)、京都大学(京都府)、市立貝塚病院(大阪府)、市立豊中病院(大阪府)、関西労災病院(兵庫県)、八尾市立病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 17 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 17
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 07 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 29 Day
Last follow-up date
2018 Year 12 Month 26 Day
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 17 Day
Last modified on
2019 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019532

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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