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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008842
Receipt No. 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 2012/09/03

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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
Middle name
Last name Masataka Hirabayashi
Organization Hyogo prefectural Amagasaki hospital
Division name Depertment of respiratory medicine
Zip code
Address Higashi-Damotsu-cho, 1-1-1, Amagasaki, Japan
TEL 06-6482-1521
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Hirabayashi
Organization Hyogo prefectural Amagasaki hospital
Division name Depertment of respiratory medicine
Zip code
Address
TEL 06-6482-1521
Homepage URL
Email

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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 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
2012 Year 09 Month 03 Day
Last modified on
2012 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010302

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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