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UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000013387
Receipt No. 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

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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
Email 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
Email taku@ks.kyorin-u.ac.jp

Sponsor
Institute Lung Cancer Experts Network (LCEN)
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015530

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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