UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013387 |
|---|---|
| Receipt number | R000015530 |
| Scientific Title | A phase II study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with pemetrexed in elderly patients with advanced epidermal growth factor receptor non-squamous non-small-cell lung cancer (LCEN1301) |
| Date of disclosure of the study information | 2014/03/11 |
| Last modified on | 2015/06/07 01:14:10 |
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Basic information
Public title
A phase II study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with pemetrexed in elderly patients with advanced epidermal growth factor receptor non-squamous non-small-cell lung cancer (LCEN1301)
Acronym
A phase II study comparing CBDCA plus PEM followed by maintenance PEM with PEM in elderly patients with advanced EGFR wild type non-sq NSCLC (LCEN1301)
Scientific Title
A phase II study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with pemetrexed in elderly patients with advanced epidermal growth factor receptor non-squamous non-small-cell lung cancer (LCEN1301)
Scientific Title:Acronym
A phase II study comparing CBDCA plus PEM followed by maintenance PEM with PEM in elderly patients with advanced EGFR wild type non-sq NSCLC (LCEN1301)
Region
| Japan |
Condition
Condition
Elderly patients with advanced non-squamous non-small-cell lung cance
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare pemetrexed/carboplatin followed by pemetrexed with pemetrexed for elderly patients with previously untreated advanced non-squamous non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
one-year survival rate
Key secondary outcomes
safety
response rate
disease control rate
progression free survival
overall survival
QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Pemetrexed (500mg/m2) given on day 1 every 3 weeks
Interventions/Control_2
B: Carboplatin (AUC 5) plus pemetrexed (500 mg/m2) given on day 1 every 3 weeks. If the patients do not develop disease progression, continuation maintenance of pemetrexed (500 mg/m2) is given on day 1 every 3 weeks until disease progression.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer
2) 75 years of age or older
3) Clinical stage IIIB (not amenable to curative radiation) and IV
4) EGFR wild type
5) ECOG performance status of 0 or 2
6) At least one measureable lesion per RECIST 1.0
6) Without symptomatic central nervous system metastases
7) Adequate organ funcion within 2 weeks
* Leukocyte count > or = 3000/mm3
* Neutrophil count > or = 2000/mm3
* Platelet count > or = 100000/mm3
* AST and ALT levels < or = 100IU/L
* Total bilirubin level < or = 1.5mg/dl
* Serum creatinine levels < or = 1.2mg/dl
* SpO2 > or = 90% (room air)
8) Estimating Survival more than 2 months
9) Controllable plueral effusion
* OK432 pleurodesis for malignant pleural effusion is acceptable.
10) Eligible in case of controlled brain metastases
11) Written informed consent
Key exclusion criteria
1) Pulmonary fibrosis and interstitial pneumonia on chest X-ray or symptomatic pulmonary fibrosis and interstitial pneumonia
2) SVC synd
3) Uncontrolled diabetes, myocardial infarction or cerebral infarction within the past 3 months
4) Infectious disease requiring systemic treatment
5) Psychotic disorder
6) Synchronous or metachronous active double malignancies
7) History of allergic reaction for agents of present treatment
8) Severe heart disease
9) Patients with immunotherapy or vaccine therapy
10) Other ineligible status judged by medical oncologist
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Yokoyama |
Organization
Kyorin University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
0422-47-5511
taku@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Yokoyama |
Organization
Kyorin University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
0422-47-5511
Homepage URL
taku@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Lung Cancer Experts Network (LCEN)
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
要町病院
杏林大学医学部付属病院
国立病院機構 東京病院
順天堂医学部附属練馬病院
帝京大学医学部附属病院
東京都保健医療公社豊島病院
東京都健康長寿医療センター
東京都立墨東病院
虎の門病院
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 11 | 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
Suspended
Date of protocol fixation
| 2013 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 18 | 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
| 2014 | Year | 03 | Month | 10 | Day |
Last modified on
| 2015 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015530
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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