UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007307 |
|---|---|
| Receipt number | R000008618 |
| Scientific Title | The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients |
| Date of disclosure of the study information | 2012/02/16 |
| Last modified on | 2016/06/21 23:03:30 |
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Basic information
Public title
The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Acronym
The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Scientific Title
The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Scientific Title:Acronym
The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
A two or more-Grade skin adverse event rate
Key secondary outcomes
Adverse events
Skin adverse event rate and revelation time
A two or more-Grade skin adverse event revelation time
Erlotinib administration rate
QOL(EuroQol Group EQ-5D-3L)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
erlotinib 150mg/day
prednisolone 10mg/ day 4weeks
Interventions/Control_2
erlotinib 150mg/day
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 or cytological confirmed non-small cell lung cancer
2. Age: 20years old or older
3. ECOG PS: 0-2
4. Adequate organ function
5. Life expectancy more than 3 months
6. Written informed consent from the patient
Key exclusion criteria
1. History of severe drug allergy
2.Prior treatment with drugs (Gefitinib or Cetuximab)which act on an EGFR system.
3.The patient by whom revelation of a critical adverse event is expected with a prednisolone tablet
4. Pregnant or breast-feeding females
5.Patient of the past of an active interstitial lung obstacle or a merger
6. Uncontrollable infectious disease
7. Uncontrollable peptic ulcer
8. Glaucomatous patient
9. Patient of serious illness skin disease
10. The patient who has critical complications. (Uncontrollable cardiac disease, liver cirrhosis, continuous watery diarrhea)
11. The patient in whom oral ingestion is impossible.
12. Decision of ineligibility by a physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo chida |
Organization
Hamamatsu University School of Medicine
Division name
Respiratory Medicine, Second Division, Department of Internal Medicine
Zip code
Address
20-1, 1-chome, Handayama, higashi-ku, Hamamatsu-city, Shizuoka-pref. Japan
TEL
053-435-2263
sagisakas@hospital.iwata.shizuoka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Sagisaka |
Organization
Iwata City Hospital
Division name
Respiratory Medicine
Zip code
Address
3-512, Ohkubo, Iwata-city, Shizuoka-pref. Japan
TEL
0538-38-5000
Homepage URL
sagisakas@hospital.iwata.shizuoka.jp
Sponsor or person
Institute
Respiratory Medicine, Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Respiratory Medicine, Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwata City Hospital
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 | 02 | Month | 16 | 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
| 2011 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 16 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008618
| 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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| Registered date | File name |
