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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011325
Receipt No. R000012988
Scientific Title Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia
Date of disclosure of the study information 2013/07/31
Last modified on 2017/08/20

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Basic information
Public title Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia
Acronym Phase II study of Pemetrexed + Carboplatin for lung cancer with interstitial pneumonia
Scientific Title Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia
Scientific Title:Acronym Phase II study of Pemetrexed + Carboplatin for lung cancer with interstitial pneumonia
Region
Japan

Condition
Condition no-small and non-squamous lung cancer with interstitial penumonia
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of carboplatin and pemetrexed combination therapy for non-small and non-squamous lung cancer with interstitial pneumonia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The frequency of severe lung injury on 28 days after the last chemotherapy
Key secondary outcomes Response rate, disease control rate, 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 Pemetrexed and carboplatin combination therapy
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Non-small and non-squamous lung cancer
2) Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT
3) No indication of radiation therapy and surgical resection
4) Chemotherapy naive patients
5) Age over 20 -79 years
6) ECOG Performance status 0-1
7) %FVC >= 66% and %DLCO >= 36% for each predictive values within a month of registration
8) Adequate organ function
9) Life expectancy > 3 months
10) Signed informed consent
Key exclusion criteria 1) Having uncontroled infection
2) Having a fever (more than 38 degrees
(Celsius))
3) Having past history of acute exacerbation of interstitial pneumonia
4) Progression of interstitial pneumonia on chest CT within 3 months
5) Over 21mg/day dose of predonisolone
6) Sarcoidosis and collagen vascular diseases
7) Having past history of drug-induced lung injury and radiation pnumonitis
8) Having severe complications
9) Active concomitant malignancy without evidence of recurrence within 5 years
10) Having an uncontrolable pleural effusion
11) Having allergy for pemetrexed or carboplatin
12) History of pregnancy or lactation
13) Decision of ineligibility by the attending physician
Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Respiratory Medicine and Allergy
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi
TEL 0561-82-5101
Email lung@tosei.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akira Shiraki
Organization Ogaki Municipal Hospital
Division name Respiratory Medicine
Zip code
Address 4-86 Minaminokawa-cho, Ogaki, Gifu
TEL 0584-81-3341
Homepage URL
Email akira.shiraki@gmail.com

Sponsor
Institute Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization Central Japan Lung Study Group (CJLSG)
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
2013 Year 07 Month 31 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 No longer recruiting
Date of protocol fixation
2013 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 31 Day
Last modified on
2017 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012988

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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