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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004866
Receipt No. R000005793
Scientific Title Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Date of disclosure of the study information 2011/01/14
Last modified on 2019/01/21

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Basic information
Public title Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Acronym Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Scientific Title Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Scientific Title:Acronym Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Region
Japan

Condition
Condition non small and non squamous lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 feasibility study
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes feasibility study (4 courses)
Key secondary outcomes 1-year recurrence-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, Carboplatin
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Initial chemottherapy
2.ECOG performance status0-1
3.Stage IIor III after complete resection
4.Age of 20 years or older
5.Laboratory parameters obtained before registation
WBC count:>4000/uL, <12000/uL
neutrophil count:>2000/uL
Platelet count:>10*10000/uL
Hemoglobin:>9.5g/dL
GOT,GPT:<100 IU/L
Total bilirubin:<2.0mg/dL
PaO2:>60 torr
creatinine:<1.5mg/dL
6.Anticipated life expectancy of at least 3 months
7.Capable to registrate in 30days after surgery
8.Capable to stay in the hospital
9.Obtained informed consent
Key exclusion criteria 1.Interstitial pneumonia or pulmonary fibrosis on Chest Xray
2.Unstable pleural effusion formation
3.Superior vena cava syndrome
4.Uncotrolled diabetes mellitus, hypertension, liver dysfunction, angina pectoris, and acute myocardial infarction
5.Severe infection, a sign of severe infection
6.Grade2 or worse peripheral nerve disorder at the time of enrollment
7.Regular user of NSAIDs
8.Pregnant woman, lactating woman, woman of child-bearing potential, woman who wish to pregnancy
9.Severe drug allergy
10.Severe complication
11Other inadequate reasons
12.New lesion that is recognized before enrollment

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuaki Sakai
Organization University of Tsukuba
Division name Department of Thoracic Surgery
Zip code
Address 1-1-1 Tennoudai, Tsukuba, Japan
TEL 029-853-3097
Email misakai@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuaki Sakai
Organization University of Tsukuba
Division name Department of Thoracic Surgery
Zip code
Address 1-1-1Tennoudai, Tsukuba, Japan
TEL 029-853-3097
Homepage URL http://www.md.tsukuba.ac.jp/
Email misakai@md.tsukuba.ac.jp

Sponsor
Institute Department of Thoracic Surgery,
University of Tsukuba
Institute
Department

Funding Source
Organization Department of Thoracic Surgery,
University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2011 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://jlcs55.umin.jp/program.html
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 No longer recruiting
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 13 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005793

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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