UMIN-CTR Clinical Trial

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
Email	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
Email	hirabayasi@hp.pref.hyogo.jp

Sponsor
Institute	Kansai Clinical Oncology Group
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010302