UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015991 |
|---|---|
| Receipt number | R000017502 |
| Scientific Title | A prospective study of feasibility of out-patient chemotherapy among geriatric patients with cancer |
| Date of disclosure of the study information | 2014/12/18 |
| Last modified on | 2014/12/18 17:49:23 |
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Basic information
Public title
A prospective study of feasibility of out-patient chemotherapy among geriatric patients with cancer
Acronym
GA study
Scientific Title
A prospective study of feasibility of out-patient chemotherapy among geriatric patients with cancer
Scientific Title:Acronym
GA study
Region
| Japan |
Condition
Condition
out-patient chemotherapy with cancer of age over 70
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the feasibility of out-patient chemotherapy among geriatric patients with cancer using multiple geriatric assessments tool.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the feasibility of out-patient chemotherapy
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
questionnaire
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients who had histologically confirmed malignancy
2.Age over 70
3.Patients who have not received chemotherapy with intravenous administration
4.Patients who plan out-patients chemotherapy
5.Enable to read and write Japanese
Key exclusion criteria
1.Patients who have consciousnes
2.Patients who have severe physical symptoms
3.Patients who have severe mental disorder,for example uncontrolled schizophrenia
4.Patients judged inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya university
Division name
Department of Clinical Chemotherapy and Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya-city
TEL
052-744-1902
yando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Hayashi |
Organization
Nagoya university
Division name
Department of Clinical Chemotherapy and Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya-city
TEL
052-744-1902
Homepage URL
naomi-hayashi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya university
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
| 2014 | Year | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | 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
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2014 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017502
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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