UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025666 |
|---|---|
| Receipt number | R000029383 |
| Scientific Title | The efficacy of dexamethasone for pemetrexed-induced rash prevention |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/01/21 18:07:25 |
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Basic information
Public title
The efficacy of dexamethasone for pemetrexed-induced rash prevention
Acronym
The efficacy of dexamethasone for PEM-induced rash prevention
Scientific Title
The efficacy of dexamethasone for pemetrexed-induced rash prevention
Scientific Title:Acronym
The efficacy of dexamethasone for PEM-induced rash prevention
Region
| Japan |
Condition
Condition
non-small cell lung cancer, malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of supplementary dexamethasone for pemetrexed-induced rash prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of rash within 21 days of pemetrexed administration
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
2 mg/day of dexamethasone is administrated for 5 days, two days later from pemetrexed administration
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-squamous non-small cell lung cancer or malignant pleural mesothelioma, and adequate pemetrexed treatment
2)ECOG-PS 0-2
3)Patients aged 18 or over
4)Folic acid and vitamin B12 was provided at least 1 week before day 1
5)Hospitalized at starting chemotherapy including pemetrexed
6)Meets the following criteria within 14 days before enrollment
(a)Hemoglobin level of more than 9.0 g/dL
(b)Neutrophil cout of more than 1500/mm3
(c)Platelet cout of more than 100000/mm3
(d)Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range.
(e)Aspartate transaminase (AST), alanine transaminase(ALT): less than 3 times the upper limit of normal of the institutional reference range.
(f)Creatinine clearance of less than 45mL/min.
7)Written informed consent.
Key exclusion criteria
1)Patients with contraindication of dexamethasone or pemetrexed
2)Using systemic corticosteroid
3)Patients with active infection
4)Using anti-allergenic drug
5)Patients with severe diabetes mellitus that corticosteroids administration is unacceptable
6)Patients with active for hepatitis B antigen and anti-hepatitis C antibody
7)Pregnant / lactating woman, a woman with an intention of pregnancy, a man with a partner who has an intention of pregnancy
8)Combination with cisplatin
9)Patients are judged unqualified for this study by attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Nishioka |
| Middle name | |
| Last name | Yasuhiko |
Organization
Tokushima University Hospital
Division name
Department of Respiratory medicine and Rheumatology
Zip code
7708503
Address
3-18-15, Kuramoto-cho, Tokushima, Japan
TEL
+81-88-633-7127
yasuhiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakurada |
| Middle name | |
| Last name | Takumi |
Organization
Tokushima University Hospital
Division name
Department of Pharmacy
Zip code
7708503
Address
2-50-1, Kuramoto-cho, Tokushima, Japan
TEL
+81-88-633-7471
Homepage URL
sakurada@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Respiratory medicine and Rheumatology, Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima, Japan
Tel
+81-88-633-9294
awachiken@tokushima-u.ac.jp
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 | 04 | 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
25
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
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 22 | Day |
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 | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029383
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| Registered date | File name |
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