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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003393
Receipt No. R000004079
Scientific Title Phase 2 study of Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer without EGFR Mutation (CJLSG0906)
Date of disclosure of the study information 2010/03/29
Last modified on 2016/03/28

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Basic information
Public title Phase 2 study of Pemetrexed + Carboplatin as first line therapy
for non-squamous non-small cell lung cancer without EGFR Mutation (CJLSG0906)
Acronym Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer without EGFR Mutation
Scientific Title Phase 2 study of Pemetrexed + Carboplatin as first line therapy
for non-squamous non-small cell lung cancer without EGFR Mutation (CJLSG0906)
Scientific Title:Acronym Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer without EGFR Mutation
Region
Japan

Condition
Condition Advanced non-squamous non-small cell lung cancer without EGFR Mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of combination therapy with pemetrexed and carboplatin for non-squamous non small cell lung cancer patients without epidermal growth factor receptor mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Adverse events
Disease control rate
Overall survival
Progression free survival

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Pemetrexed 500mg/m2 day1 + Carboplatin AUC6 day1, q3w, 3-6 cycles
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male
Key inclusion criteria 1) Histologically or cytologically proven non-squamous non small cell lung cancer
2) Patients with EGFR wild type
3) Patients with stage IIIB or IV, or recurrent disease after surgery and was not a candidate for curative radiotherapy
4) No prior chemotherapy
5) Patient who has measurable lesion by RECIST
6) Age: 20-74
7) ECOG PS: 0-1
8) Adequate organ function
9) Life expectancy more than 3 months
10) Written informed consent
Key exclusion criteria 1) Active infection
2) Fever
3) Serious disease condition
4) Active double cancer
5) Symptomatic brain metastasis
6) Cavity fluid retention difficult to control
7) Severe drug allergy
8) Pregnancy or lactation
9) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 53

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Respiratory medicine and allerg
Zip code
Address 160 Nishi-oiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Email taniguchi@tosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Kimura
Organization Tosei General Hospital
Division name Respiratory medicine and allergy
Zip code
Address 160 Nishi-oiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Homepage URL
Email lung@tosei.or.jp

Sponsor
Institute Central Japan Lung Study Group
Institute
Department

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
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
2010 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2010 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2014 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 28 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004079

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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