UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000781 |
|---|---|
| Receipt number | R000000936 |
| Scientific Title | Randomized phase II trial of adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX) for completely resected non-small cell lung cancer |
| Date of disclosure of the study information | 2007/08/01 |
| Last modified on | 2014/07/30 13:06:23 |
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Basic information
Public title
Randomized phase II trial of adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX) for completely resected non-small cell lung cancer
Acronym
CBDCA+GEM vs TS1+DTX phase II trial for completely resected lung cancer
Scientific Title
Randomized phase II trial of adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX) for completely resected non-small cell lung cancer
Scientific Title:Acronym
CBDCA+GEM vs TS1+DTX phase II trial for completely resected lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relapse free survival of completely resected non-small cell lung cancer with adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year relapse free survival
Key secondary outcomes
toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adjuvant chemotherapy with CBDCA+GEM
Interventions/Control_2
adjuvant chemotherapy with TS1+DTX
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
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
non-small cell lung cancer
lobectomy or more with ND2 lymphnode dissection
complete resection
pathological stage IB, II, IIIA
ECOG performance status 0, 1
Key exclusion criteria
symptomatic interstitial pneumonia
multiple lung cancer or other-type cancer within 5 years
severe organ failure
past history of radiotherapy or chemotherapy
pregnant or expecting mother
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Tsushima |
Organization
Hirosaki University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
53Honcho, Hirosaki, Aomori
TEL
0172-39-5074
tsusim@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Endo |
Organization
Japanese Northern East Area Thoracic Surgery Study Group
Division name
Central study center
Zip code
Address
4-1Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8526
Homepage URL
endo@idac.tohoku.ac.jp
Sponsor or person
Institute
Japanese Northern East Area Thoracic Surgery Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
弘前大学病院（青森県）、青森県立中央病院（青森県）、岩手県立胆沢病院（岩手県）、東北大学病院（宮城県）、宮城がんセンター（宮城県）、山形大学病院（山形県）、福島医大病院（福島県）、太田西の内病院（福島県）、総合南東北病院（福島県）、金沢医大病院（石川県）、芳珠記念病院（石川県）、獨協医大病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 08 | Month | 01 | 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
| 2007 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 30 | Day |
Last modified on
| 2014 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000936
