UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002855 |
|---|---|
| Receipt number | 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 | 2019/12/15 12:34:55 |
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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 | Makoto |
| Middle name | |
| Last name | Nishio |
Organization
Cancer Instiute Hospital
Japanese Foundation Cancer Reseach
Division name
Toracic Medical Oncology of Toracic Center
Zip code
135-8550
Address
3-8-31 Ariake,Koto-ku,Tokyo,JAPAN
TEL
03-3520-0111
mnishio@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Horiike |
Organization
Cancer Instiute Hospital
Division name
Toracic Medical Oncology of Toracic Center
Zip code
135-8550
Address
3-8-31 Ariake,Koto-ku,Tokyo,JAPAN
TEL
03-3520-0111
Homepage URL
atsushi.horiike@jfcr.or.jp
Sponsor or person
Institute
Toracic Medical Oncology of Toracic Center
Cancer Instiute Hospital
Japanese Foundation Cancer Reseach
Institute
Department
Personal name
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
IRB of Cancer Instiute Hospital Japanese Foundation Cancer Reseach
Address
3-8-31 Ariake,Koto-ku,Tokyo,JAPAN
Tel
03-3520-0111
med.shinsa@jfcr.or.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
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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | 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
| 2009 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003476
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/12/15 | adjuvant CDDP＋GEM 計画書改訂3版.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/12/15 | adjuvant CDDP+GEM PII-1.xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/12/15 | adjuvant CDDP+GEM PII肺癌学会総会2015.pdf |
