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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009366
Receipt No. R000011006
Scientific Title An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer
Date of disclosure of the study information 2012/11/20
Last modified on 2019/05/27

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Basic information
Public title An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer
Acronym Predictive factors for adverse effects of pemetrexed
Scientific Title An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer
Scientific Title:Acronym Predictive factors for adverse effects of pemetrexed
Region
Japan

Condition
Condition non-squamous and non-small cell lung cancer, pleural mesothelioma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To find biological or genetical predictive factors for adverse effects of pemetrexed in patients with lung cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Adverse effects during 2 cycles of pemetrexed including chemotherapy
Key secondary outcomes Response rate by RECIST criteria
Progression free survival

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Histologically or cytologically confirmed non-squamous and non-small cell lung cancer and malignant pleural mesothelioma
2) Stage IIIB without any indication for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy
3) Treated with pemetrexed including regimen
4) ECOG PS 0-1
5) 20 years old or older
6) With or without measurable lesion
7) Adequate organ function evaluated within 14 days before enrollment
8) Life expectancy more than 12 weeks
9) Written informed consent
Key exclusion criteria 1) Treated with concurrent radiotherapy
2) Inappropriate for administration of pemetrexed
a) a history of serious drug hypersensitivity
b) severe myelosuppression, renal or hepatic dysfunction
c) contraindicated for the use of pemetrexed
d) severe comorbid disease
e) administration of systemic antimicrobial agents
f) continuous drainage for pleural effusion, ascites or cardiac effusion
g) brain metastasis with any symptoms
h) administration of systemic steroid
i) pregnancy, lactation or intention to pregnancy
j) judged to have difficulty in participation in this study because of psychosis or neurologic disease
k) judged to be inadequate for this study by doctors

Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Takeda
Organization National center for global health and medicine
Division name Department of Respiratory Medicine
Zip code 162-8655
Address 1-21-1 Toyama Shinjyuku-ku, Tokyo
TEL 03-3202-7181
Email ytakeda@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Yuichiro
Middle name
Last name Takeda
Organization National center for global health and medicine
Division name Department of Respiratory Medicine
Zip code 162-8655
Address 1-21-1 Toyama Shinjyuku-ku, Tokyo
TEL 03-3202-7181
Homepage URL
Email ytakeda@hosp.ncgm.go.jp

Sponsor
Institute National center for global health and medicine
Institute
Department

Funding Source
Organization Foundation of National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Medical oncology, Funabashi Municipal Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Clinical sciences, National Center for Global health and Medicine
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.go.jp

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 国立国際医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 20 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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
2019 Year 05 Month 14 Day
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 30 Day
Date trial data considered complete
2020 Year 05 Month 31 Day
Date analysis concluded
2020 Year 07 Month 31 Day

Other
Other related information An exploratory study to find biological or genetical predictive factors for adverse effects of pemetrexed in patients with non-squamous and non-small cell lung cancer

Management information
Registered date
2012 Year 11 Month 19 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011006

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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