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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002846
Receipt No. R000003473
Scientific Title Phase II study of pematrexed plus carboplatin in previously untreated non-small cell, non-squamous cell lung cancer
Date of disclosure of the study information 2009/12/04
Last modified on 2012/12/10

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Basic information
Public title Phase II study of pematrexed plus carboplatin in previously untreated non-small cell, non-squamous cell lung cancer
Acronym Phase II trial of PEM/CBDCA for NSCLC
Scientific Title Phase II study of pematrexed plus carboplatin in previously untreated non-small cell, non-squamous cell lung cancer
Scientific Title:Acronym Phase II trial of PEM/CBDCA for NSCLC
Region
Japan

Condition
Condition Unresectable non-small cell lung cancer with EGFR mutations (non-squamous histology)
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate efficacy and safety in combination of pemeterexed and carboplatin in non-small cell lung cancer (non-squamous histology)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes safety, overall survival, and 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 Chemotherapy (Carboplatin + Pemetrexed)
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 proven NSCLC (non-squamous histology)
2) Chemotherapy-naive patients
3) Relapsed NSCLC without adjuvant chemotherapy is also eligible
4) Stage IIIB, IV NSCLC
5) At least one measurable lesion
6) Over 20 years old and under 75 years old
7) ECOG performance status of 0-1
8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= 100 (<= 150 case with liver mets), T-bilirubin <= 1.5 mg/dl, Cr <= 1.2 mg/dl, creatinin clearance >= 60 ml/min, PaO2 or SpO2 >= 60 Torr or 95%)
9) Life expectancy of at least 12 weeks
10) Written informed consent
Key exclusion criteria 1) Active infection
2) fever >= 38C
3) Severe and uncontrolled complication 4) Other active malignancies
5) Unstable metastases to the brain
6) Uncontrolled pleural, pericardial effusion or ascites
7) Presence of active interstitial pneumonia
8) Allergy to treatment drugs
9) Pregnant patients
10) Unstable psychic disorder
11) Continuous use of steroid
12) Decision of ineligibility by a physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Ishida
Organization Fukushima Medicl University, School of Medicine
Division name Pulmonary Medicine
Zip code
Address 960-1295 Hikarigaoka 1, Fukushima city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Fukushima Medicl University, School of Medicine
Division name Pulmonary Medicine
Zip code
Address
TEL 024-547-1111
Homepage URL
Email

Sponsor
Institute Hokkaido Lung Cancer Study Group
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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 04 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 Completed
Date of protocol fixation
2009 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 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
2009 Year 12 Month 04 Day
Last modified on
2012 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003473

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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