UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025541 |
|---|---|
| Receipt number | R000029399 |
| Scientific Title | The phase II study to clarify the usefulness of swallow ability test and pneumonia prediction program in elderly patients with gastric cancer |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2017/01/05 15:25:33 |
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Basic information
Public title
The phase II study to clarify the usefulness of swallow ability test and pneumonia prediction program in elderly patients with gastric cancer
Acronym
Pneumonia prediction in elderly patients with gastric cancer
Scientific Title
The phase II study to clarify the usefulness of swallow ability test and pneumonia prediction program in elderly patients with gastric cancer
Scientific Title:Acronym
Pneumonia prediction in elderly patients with gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the aim of thie single-center prospective phase II study was to clarify the usefulnesss of swallow ability screening and pneumonia prediction program for elderly patients with gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative pneumonia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
wallow ability screening and pneumonia prediction program
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically confirmed adenocarcinoma
of the stomach
2) sufficient oral intake
3) patient age of 75 years or more
4) an Eastern Cooperative Oncology
Group performance status of 0-1
5) no prior chemotherapy or radiotherapy
for any malignancy
6) adequate organ function
7) written informed consent.
Key exclusion criteria
1) with infection conditions
2) with mental disease
3) patients who take systemic steroid therapy
4) patients who take insulin therapy
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Terashima |
Organization
Shizuoka Cancer Center
Division name
Gastric Surgery
Zip code
Address
1007, Shimonagakubo, Nagaizumi, Suntogun, Shizuoka
TEL
055-989-5222
m.terashima@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro MIki |
Organization
Osaka City University
Division name
Surgical Oncology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
0666452121
Homepage URL
y_miki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
Organization
Division
Category of Funding Organization
Local Government
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
| 2017 | Year | 01 | Month | 05 | 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 | 01 | Month | 20 | 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
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029399
