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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017123
Receipt No. R000019709
Scientific Title Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Date of disclosure of the study information 2015/05/01
Last modified on 2018/04/17

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Basic information
Public title Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Acronym Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Scientific Title Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Scientific Title:Acronym Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Region
Japan

Condition
Condition Advanced or metastatic gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility, safety, and efficacy of Propagermanium for advanced or metastatic gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Adverse events, feasibility, disease control rate, progression free survival, proportion of treatment related death, and performance status.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Propagermenium (30mg/day, every day)
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 confirmed gastric cancer
2) resistant /intolerable to other treatments
3) Measurable or non-measurable disease
4) Adequate oral intake
5) Age >= 20 years
6) Eastern Cooperative Oncology Group Performance status is 0,1,2.
7) Negative HBe antigen and no liver cirrhosis
8) Adequate renal function
9) No prior immunotherapy
10) Treatment in out-patient clinic is feasible.
11) Written informed consent
Key exclusion criteria 1) Active concomitant malignancy
2) Active infection
3) High fever (>38 degree) at registration
4) Pregnant, nursing or unwilling to practice contraception during the study
5) Poorly controlled diabetes mellitus
6) medication of steroid
7) Severe diabetes mellitus
8) Unstable angina or acute myocardial infarction within 6 months
9) Severe organ failure ( renal, hepatic pulmonary disease)
10) Active bleeding
11) Massive pleural effusion
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Sasako
Organization Hyogo College of Medicine
Division name Surgery
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6767
Email msasako@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shojiro Kikuchi
Organization Hyogo College of Medicine
Division name Surgery
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6767
Homepage URL
Email skikuchi@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 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 Completed
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019709

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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