UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005256 |
|---|---|
| Receipt number | R000006252 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC |
| Date of disclosure of the study information | 2011/03/17 |
| Last modified on | 2017/03/21 13:58:58 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Acronym
Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Scientific Title
Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Scientific Title:Acronym
Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Region
| Japan |
Condition
Condition
Completely resected NSCLC (stage IB - IIIA including multiple N2)
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate feasibility of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC (segmentectomy, lobectomy or bi-lobectomy) with staged IB to IIIA including pN2.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chemotherapy compliance in the four cycles
Key secondary outcomes
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
Period: From March 2011 to Febrary 2013
Dose:GEM 1000mg/m2 d1.d8+CDDP 80mg/m2 d1
Cycle: 4 cycles
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)The patient histologically proven as non-small cell lung cancer
(2)The patient with p-staged IB - IIIA that received segmentectomy, lobectomy, or bi-lobectomy (including multiple pN2)
(3) Performance Status is 0 - 1 (ECOG).
(4) 20 years of age or older, 80 years of age or younger.
(5) The patient who does not receive any chemotherapy, radiotherapy, or immunotherapy prior to resection
(6) The patient who preserves the main organ ( the bone marrow, liver, kidney and so on )
(7) The patient who can receive chemotherapy within 4 - 12 weeks after resection
(8) The patient who gives written informed consent
Key exclusion criteria
(1)The patient with infection
(2)The patient with fever (equal to or more than 38 C)
(3)The patient with heavy complication
(4)The patient with active double-cancer
(5)The patient with chickenpox
(6)The patient with a motor-palsy or figure of peripheral-nerve-disease
(7)The patient with drug hypersensitivity
(8)The expectant mother, the woman who has a lactating-woman and the possibility of the pregnancy
(9)The patient judged as unsuitable by the doctor
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Kumamoto University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
1-1-1 Honjo,Kumamoto
TEL
096-373-5533
smakoto@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Kumamoto University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL
096-373-5533
Homepage URL
smakoto@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 03 | Month | 17 | 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
| 2011 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 03 | Month | 16 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006252
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| Registered date | File name |
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| Registered date | File name |
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