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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002855
Receipt No. R000003476
Scientific Title A Phase II Study of Adjuvant Cisplatin and Gemsitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Date of disclosure of the study information 2009/12/07
Last modified on 2018/06/14

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Basic information
Public title A Phase II Study of Adjuvant Cisplatin and Gemsitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Acronym A Phase II Study of Adjuvant Cisplatin and Gemsitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Scientific Title A Phase II Study of Adjuvant Cisplatin and Gemsitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Scientific Title:Acronym A Phase II Study of Adjuvant Cisplatin and Gemsitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Region
Japan

Condition
Condition A Phase II Study of Adjuvant Cisplatin and Gemcitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Aim of this study is to evaluate efficacy and safety of adjuvant Cisplatin and Gemcitabine in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1-year PFS
Key secondary outcomes toxicity
complete rate of treatment

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 Gemcitabine 1000mg/m2
Cisplatin 80mg/m2
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 Histologically or cytologically confirmed diagnosis of non-small cell lung cancer.

Completely resected with documented Stage II or Stage IIIA.
Key exclusion criteria A recognized ILD or pulmonary fibrosis on X-rays.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishio
Organization Cancer Instiute Hospital
Japanese Foundation Cancer Reseach
Division name Toracic Medical Oncology of Toracic Center
Zip code
Address 3-8-31 Ariake,Koto-ku,Tokyo,JAPAN
TEL 03-3520-0111
Email mnishio@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Horiike
Organization Cancer Instiute Hospital
Division name Toracic Medical Oncology of Toracic Center
Zip code
Address 3-8-31 Ariake,Koto-ku,Tokyo,JAPAN
TEL 03-3520-0111
Homepage URL
Email atsushi.horiike@jfcr.or.jp

Sponsor
Institute Toracic Medical Oncology of Toracic Center
Cancer Instiute Hospital
Japanese Foundation Cancer Reseach
Institute
Department

Funding Source
Organization Toracic Medical Oncology of Toracic Center
Cancer Instiute Hospital
Japanese Foundation Cancer Reseach
Organization
Division
Category of Funding Organization Non profit foundation
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 07 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
2009 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 09 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 07 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003476

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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