UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008842 |
|---|---|
| Receipt number | R000010302 |
| Scientific Title | Multi-institutional randomized phase 2 trial of the combination chemotherapy of carboplatin and pemetrexed for advanced nonsquamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2012/09/03 |
| Last modified on | 2022/03/17 08:53:08 |
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Basic information
Public title
Multi-institutional randomized phase 2 trial of the combination chemotherapy of carboplatin and pemetrexed for advanced nonsquamous non-small-cell lung cancer
Acronym
KCOG-T1112
Scientific Title
Multi-institutional randomized phase 2 trial of the combination chemotherapy of carboplatin and pemetrexed for advanced nonsquamous non-small-cell lung cancer
Scientific Title:Acronym
KCOG-T1112
Region
| Japan |
Condition
Condition
Nonsquamous non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The comparison of the efficacy and safety between the continuous treatment of carboplatin plus pemetrexed and the single-agent pemetrexed maintenance therapy after four cycles of the combination chemotherapy of carboplatin and pemetrexed for advanced nonsquamous non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
One year survival and safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination chemotherapy of carboplatin and pemetrexed
Interventions/Control_2
Single-agent pemetrexed maintenance therapy
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
< First step >
1.Advanced nonsquamous non-small-cell lung cancer
2.ECOG PS0-1
3.Adequate organ function
4.Measurable disese
5.Life expectancy exceeding 3 months
6.Written informed consent
< Second step >
1.CR/PR/SD by induction therapy
2.ECOG PS0-1
3.Adequate organ function
4.Measurable disese
5.Life expectancy exceeding 3 months
6.Written informed consent
Key exclusion criteria
1.Squamous cell carcinoma
2.Irradiation for praimary lesion
3.SVC syndrome
4.Uncontrollable pleural effusion
5.Massive ascites or pericardial efusion
6.Interstitial pneumonia revealed by chestXP
7.Symptomatic brain metastasis
8.Untreated double cancer
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Hirabayashi |
Organization
Hyogo prefectural Amagasaki general medical center
Division name
Depertment of respiratory medicine
Zip code
660-8550
Address
Higashi-Naniwa-cho, 2-17-77, Amagasaki, Japan
TEL
0664807000
hirabayasi@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Hirabayashi |
Organization
Hyogo prefectural Amagasaki general medical center
Division name
Depertment of respiratory medicine
Zip code
660-8550
Address
Higashi-Naniwa-cho, 2-17-77, Amagasaki, Japan
TEL
09070949480
Homepage URL
hirabayasi@hp.pref.hyogo.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group
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
Hyogo prefectural Amagasaki general medical center
Address
Higashi-Naniwa-cho, 2-17-77, Amagasaki, Japan
Tel
0664807000
hirabayasi@hp.pref.hyogo.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
| 2012 | Year | 09 | Month | 03 | 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
20
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
| 2012 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010302
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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