UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007643 |
|---|---|
| Receipt number | R000009017 |
| Scientific Title | Phase2 study of platinum doublet with pemetrexed in non-squamous non-small cell lung cancer with brain metastases. |
| Date of disclosure of the study information | 2012/04/07 |
| Last modified on | 2014/12/30 11:30:38 |
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Basic information
Public title
Phase2 study of platinum doublet with pemetrexed in non-squamous non-small cell lung cancer with brain metastases.
Acronym
NJLCG1202
Scientific Title
Phase2 study of platinum doublet with pemetrexed in non-squamous non-small cell lung cancer with brain metastases.
Scientific Title:Acronym
NJLCG1202
Region
| Japan |
Condition
Condition
Non-small cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of platinum doublet with pemetrexed in previous untreated non-squamous non-small cell lung cancer with brain metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate in brain lesions
Key secondary outcomes
Response Rate
Progression-free Survival
Overall Survival
Safety
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
Induction therapy with platinum plus pemetrexed followed by maintenance therapy with pemetrexed until disease progression
Induction therapy:CDDP 75mg/m2 day1 or CBDCA AUC6 day1+pemetrexed 500mg/m2 day1 q3weeks,4cycles
Maintenance therapy: pemetrexed 500mg/m2 day1 q3weeks until PD.
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 and Female
Key inclusion criteria
1) Histologically or cytologically confirmed non-squamous NSCLC
2) Patients with EGFR wild type tumors
3) Unresectable NSCLC or reccurent NSCLC
4) Measurable brain and extra-brain lesions
5) Age: 20-75
6) ECOG performance status 1 or less
7) With adequate major organ functions within 14 days before randomization, as defined below:
*Neutrophil count >= 2,000/mm3
*Platelet count >= 100,000/mm3
*Hemoglobin >= 9.0 g/dL
*AST <= 2.0 x ULN
*ALT <= 2.0 x ULN
*Total bilirubin <= 1.5 mg/dL
*Estimated CCr >= 45mL/min.(CBDCA)
*Estimated CCr >= 60mL/min.(CDDP)
*PaO2 >= 60 Torr or SpO2 >= 95%
8) Life expectancy more than 3 months
9) Written informed consent
Key exclusion criteria
1) Symptomatic brain metastases
2) Radiotherapy for brain metastases
3) Interstitial lung disease or lung fibrosis detectable or chest X-ray
4) Taking systematic administration of steroid for more than 4 weeks
5) Pleural or cardiac effusion that needs to drain
6) Severe comorbidities
7) Active co-existent malignancies
8) Pregnant patients
9) Other conditions inadequate for this study
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
Dept. of Respiratory Medicine
Zip code
Address
47-1 Nodayama, Medesima-shiote, Natori, Miyagi, 981-1293, Japan
TEL
81-22-384-3151
maemondo-ma693@miyagi-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Dept. of Respiratory Medicine
Division name
Dept. of Respiratory Medicine
Zip code
Address
47-1 Nodayama, Medesima-shiote, Natori, Miyagi, 981-1293, Japan
TEL
81-22-384-3151
Homepage URL
maemondo-ma693@miyagi-pho.jp
Sponsor or person
Institute
North Japan Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
North Japan Lung Cancer Study Group
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
YES
Study ID_1
NJLCG
Org. issuing International ID_1
North Japan Lung Cancer Study Group
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 | 04 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 16 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009017
