UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000913 |
|---|---|
| Receipt number | R000001102 |
| Scientific Title | Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer |
| Date of disclosure of the study information | 2007/11/29 |
| Last modified on | 2019/06/11 17:54:32 |
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Basic information
Public title
Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Acronym
Randomized phase II trial of CBDCA/GEM versus CDDP/GEM for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Scientific Title
Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Scientific Title:Acronym
Randomized phase II trial of CBDCA/GEM versus CDDP/GEM for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
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 (CDDP+GEM vs CBDCA+GEM)
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
Safety
Feasibility
Overall survival time
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 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
adjuvant chemotherapy with CDDP+GEM
Interventions/Control_2
adjuvant chemotherapy with CBDCA+GEM
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. pathologically proven non-small cell lung cancer
2. complete resection
3. pathological stage IB, II, and stage IIIA
4. no prior anti cancer treatment for thoracic malignancy except for this operation
5. Performance status(ECOG)0-1
6. adequate organ function for chemotherapy
7. written informed consent
Key exclusion criteria
1. sever infection
2. uncontrolled Diabetes Mellitus and hypertension, unstable angina or Myocardial Infarction within 6 months
3. apparent interstitial pneumonitis at chest rentogenogram
4. Uncontrollable pleural effusion
5. multiple lung cancer or other-type cancer within 5 years
6. History of severe hypersensitivity
7. Pregnant or expecting woman
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Harada |
Organization
Hokkaido Lung Cancer Clinical Study Group
Division name
Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center
Zip code
0030804
Address
4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan
TEL
011-811-9111
fukumoto.shinichi.ad@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Fukumoto |
Organization
Hokkaido Lung Cancer Clinical Study Group
Division name
Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center
Zip code
0030804
Address
4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan
TEL
011-811-9111
Homepage URL
fukumoto.shinichi.ad@mail.hosp.go.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group
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
National Hospital Organization Hokkaido Cancer Center
Address
4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan
Tel
011-811-9111
fukumoto.shinichi.ad@mail.hosp.go.jp
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 | 11 | Month | 29 | 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
Main results already published
Date of protocol fixation
| 2007 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 29 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001102
