UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005901 |
|---|---|
| Receipt number | R000006978 |
| Scientific Title | A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer |
| Date of disclosure of the study information | 2011/07/02 |
| Last modified on | 2014/01/02 15:27:08 |
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Basic information
Public title
A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
Acronym
A phase III trial of adjuvant therapy with irsogladine maleate for the resected lung cancer patient
Scientific Title
A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
Scientific Title:Acronym
A phase III trial of adjuvant therapy with irsogladine maleate for the resected lung cancer patient
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 elucidate whether the prognoses of the resected lung cancer patients would improve or not after the administration of irsogladine maleate for 2 years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
relapse-free survival
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
For the patient with rescted stage IA lung cancer, no adjuvant therapy is performed. For the patient with resected stage IB - IIIA, administration of tegafur-uracil for 2 years is performed.
Interventions/Control_2
For the patient with rescted stage IA lung cancer, administration of irsogladine maleate for 2 years is performed. For the patient with resected stage IB - IIIA, administration of tegafur-uracil and irsogladine maleate for 2 years is performed.
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
| 25 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
non-small cell lung cancer
after complete resection
after lobectomy or peumonectomy
after hilar and mediastinal dissection
pathological stage IA - IIIA
no prior treatment
ECOG performance status 0-1
sufficient organ functions
written informed consent
Key exclusion criteria
multiple cancer within 5 years
sever organ failure
past history of radiotherapy/chemotherapy
women with pregnancy or breast feeding
Target sample size
310
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kondo |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Thoracic Surgery
Zip code
Address
4-1Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8521
sagawam@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyasu Sagawa |
Organization
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Division name
Central study center
Zip code
Address
4-1Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8526
Homepage URL
sagawam@kanazawa-med.ac.jp
Sponsor or person
Institute
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.minervamedica.it/en/journals/minerva-chirurgica/
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
| 2000 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 01 | Day |
Last modified on
| 2014 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
