UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007790 |
|---|---|
| Receipt number | R000009180 |
| Scientific Title | A randomized trial of adjuvant chemotherapy in resected stage I lung adenocarcinoma with high SUV index. JNETS 1201 |
| Date of disclosure of the study information | 2012/04/20 |
| Last modified on | 2014/03/04 15:37:27 |
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Basic information
Public title
A randomized trial of adjuvant chemotherapy in resected stage I lung adenocarcinoma with high SUV index. JNETS 1201
Acronym
Adjuvant chemotherapy in lung adenocarcinoma with high SUV index. JNETS 1201
Scientific Title
A randomized trial of adjuvant chemotherapy in resected stage I lung adenocarcinoma with high SUV index. JNETS 1201
Scientific Title:Acronym
Adjuvant chemotherapy in lung adenocarcinoma with high SUV index. JNETS 1201
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of adjuvant chemotherapy for resected stage I lung adenocarcinoma with high SUV index.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease-free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control n=230(stage IA: no chemotherapy, stage IB: UFT)
Interventions/Control_2
Trial n=230 (stage IA: UFT, stage IB: chemotherapy with CDDP or CBDCA)
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
p-stage I lung adenocarcinoma with SUV index with 1 or more.
Key exclusion criteria
non-p-stage I lung adenocarcinoma with SUV index with 1 or more.
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kondo |
Organization
Tohoku University, school of medicine
Division name
Department of thoracic surgery,
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8526
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Shiono |
Organization
Yamagata Prefectural Central Hospital
Division name
Department of thoracic surgery
Zip code
Address
1800, Ooazaaoyagi, Yamagata
TEL
023-685-2626
Homepage URL
Sponsor or person
Institute
Japanese Northern East Area Thoracic Surgery Study Group (JNETS-SG)
Institute
Department
Personal name
Funding Source
Organization
Japanese Northern East Area Thoracic Surgery Study Group (JNETS-SG)
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 19 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009180
