UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008917 |
|---|---|
| Receipt number | R000009870 |
| Scientific Title | Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia |
| Date of disclosure of the study information | 2012/09/15 |
| Last modified on | 2012/09/27 11:28:56 |
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Basic information
Public title
Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia
Acronym
Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia
Scientific Title
Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia
Scientific Title:Acronym
Phase II study on the efficacy of Prosure in advanced or recurrent cancer with cachexia
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical efficacy (TTF, OS, PFS, PS, serum CRP, serum Albumin, BMI, TLC, safety, body weight, QOL, detachment rate from group D *) of Prosure compared with historical un-intervened group
*continuous detachment from group D longer than two weeks, when the "low albumin and high CRP group" of a cut-off of serum albumin<3.5g/dl and CRP>0.5mg/dl is allocated to group D
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
time to treatment failure (TTF) of a first-line chemotherapy
Key secondary outcomes
overall survival
progression free survival
nutritional assessment (serum CRP,serum albumin,detachment rate form group D,TLC,body weight,BMI)
QOL(Quality of life)
comparison with a control group
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
| Food |
Interventions/Control_1
administration of two packs (480 ml) daily of Prosure for 6 month
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- advanced, recurrent, or R1 or R2 post operative gastric cancer
- first-line chemotherapy
- written informed consent obtained from patients or or legal representatives
- male or female of 20 - 80 years-old at informed consent
- ability of oral intake and maintained gastrointestinal function
- estimated prognosis longer than three months (PS0 - 2)
- albumin<3.5g/dl and CRP>=0.5mg/dl
- assured tolerance to Prosure at pre-interventional test
Key exclusion criteria
- intestinal obstruction (inability of oral intake)
- obvious infection focus
- severe heart, liver, or kidney disease
- uncontrollable diabetes mellitus
- hyperlipidemia resistant to treatment
- past history of chronic inflammatory disease
- past history of allergy to contents of Prosure (milk, soybean etc)
- probable pregnancy and/or lactation
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Imamura |
Organization
Sakai City Hospital
Division name
Surgery
Zip code
Address
1-1-1 Minamiyasui Cho, Sakai City, Osaka, Japan
TEL
0722-21-1700
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Imamura |
Organization
Sakai City Hospital
Division name
Surgery
Zip code
Address
1-1-1 Minamiyasui Cho, Sakai City, Osaka, Japan
TEL
0722-21-1700
Homepage URL
Sponsor or person
Institute
Nutrition on Cancer Chemotherapy Conference
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 09 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 14 | Day |
Last modified on
| 2012 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009870
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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