UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003393 |
|---|---|
| Receipt number | 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 20:25:55 |
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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
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
lung@tosei.or.jp
Sponsor or person
Institute
Central Japan Lung Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004079
