UMIN-CTR Clinical Trial

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
Email	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
Email	fukumoto.shinichi.ad@mail.hosp.go.jp

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001102