UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000705 |
|---|---|
| Receipt number | R000000841 |
| Scientific Title | Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer. |
| Date of disclosure of the study information | 2007/05/14 |
| Last modified on | 2009/10/21 13:12:45 |
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Basic information
Public title
Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Acronym
Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Scientific Title
Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Scientific Title:Acronym
Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Region
| Japan |
Condition
Condition
in patients with completely resected stage IB-IIIA non-small-cell
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
treatment compliance
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
treatment compliance rate is 70% or more.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients completely resected p-stage IB-IIIA non–small-cell lung cancer with acceptable baseline characteristics and an ECOG performance status of 0 or 1 were eligible
Key exclusion criteria
Patients with incomplete resection, wedge resection, clinically significant cardiac dysfunction, active infection, Varicella, or critical complications, neurologic or psychiatric disorders, and patients who had had other cancers treated within the previous five years were ineligible. Pregnant woman were also ineligible. Patients decided to be unsuitable by the doctor was ineligible.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
Address
1-20-1 Handayama, Higashi, Hamamatsu, 431-3192,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
Address
TEL
Homepage URL
kfunai@hmedc.or.jp
Sponsor or person
Institute
First Department of Surgery
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
| 2007 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2006 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2007 | Year | 05 | Month | 02 | 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=R000000841
