UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001446 |
|---|---|
| Receipt number | R000001754 |
| Scientific Title | Dose-escalation study of adjuvant vinorelbine plus cisplatin with Japanese completely resected stage I-IIIA non-small-cell lung cancer |
| Date of disclosure of the study information | 2008/10/21 |
| Last modified on | 2009/10/21 13:12:09 |
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Basic information
Public title
Dose-escalation study of adjuvant vinorelbine plus cisplatin with Japanese completely resected stage I-IIIA non-small-cell lung cancer
Acronym
Dose-escalation study of adjuvant vinorelbine plus cisplatin with Japanese completely resected non-small-cell lung cancer
Scientific Title
Dose-escalation study of adjuvant vinorelbine plus cisplatin with Japanese completely resected stage I-IIIA non-small-cell lung cancer
Scientific Title:Acronym
Dose-escalation study of adjuvant vinorelbine plus cisplatin with Japanese completely resected non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Patients with completely resected non-small-cell lung cancer with stage IB-IIIA and stage IA with 2cm or more
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed maximum tolerance dose in the adjuvant chemotherapy by cisplatin + vinorelvin in Japanese
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum tolerance dose
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
Level 1: Vinorelbin (20mg/m2)+Cisplatin (40mg/m2)
Level 2: Vinorelbin (25mg/m2)+Cisplatin (40mg/m2)
Level 3: Vinorelbin (25mg/m2)+Cisplatin (45mg/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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.pathological stage IB, II,IIIA and stage IA with 2cm or more
disease
2.completely resected non small cell lung cancer
3.18 years or older
4.PS 0-1
5.adequate oragan function for chemotherapy
7.written informed consent
Key exclusion criteria
1.inadequate conditon for chemotherapy
2.Patients with a histoly of concurrent malignancy sidease were excluded
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Momiki |
Organization
Hamamatsu medicar cencer
Division name
Division of Thoracic Surgery
Zip code
Address
328, Tomiduka, Naka, Hamamatsu, Shizuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu Medicar Cencer
Division name
Thoracic surgery
Zip code
Address
TEL
Homepage URL
kfunai@hmedc.or.jp
Sponsor or person
Institute
Hamamatsu Medical Cencer
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2008 | Year | 10 | Month | 21 | 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
| 2008 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | 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
| 2008 | Year | 10 | Month | 21 | Day |
Last modified on
| 2009 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001754
| 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 |
