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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004386
Receipt No. R000003754
Scientific Title Randomized Phase II trial of 1st-line biweekly Gemcitabine (G) and Carboplatin (C) vs biweekly Gemcitabine (G) and Carboplatin (C)plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)
Date of disclosure of the study information 2010/10/14
Last modified on 2014/09/09

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Basic information
Public title Randomized Phase II trial of 1st-line biweekly Gemcitabine (G) and Carboplatin (C) vs biweekly Gemcitabine (G) and Carboplatin (C)plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)
Acronym Randomized PhaseII trial of 1st-line biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)
Scientific Title Randomized Phase II trial of 1st-line biweekly Gemcitabine (G) and Carboplatin (C) vs biweekly Gemcitabine (G) and Carboplatin (C)plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)
Scientific Title:Acronym Randomized PhaseII trial of 1st-line biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)
Region
Japan

Condition
Condition elderly patient untreated non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy in the chemotherapy with biweekly gemcitabine and carboplatin plus maintenance gemcitabine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate, Quality of life, Adverse events, Overall 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
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 4 cycles of combined chemotherapy with gemcitabine 1000mg/m2 at day1, 15 and carboplatin AUC3 at day1, 15 followed by chemotherapy with gemcitabine 1000mg/m2 at day1, 15 until PD
Interventions/Control_2 4 cycles of combined chemotherapy with gemcitabine 1000mg/m2 at day1, 15 and carboplatin AUC3 at day1, 15.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Chemotherapy-naive patients with histologically or cytologically confirmed NSCLC
2)Measurable lesion according to the RECIST
3)Stage IIIB not amenable to curative treatment or stage IV
4)Over 70 years of age
5)PS0, 1
6)Apropriate organ function
7)Life expectancy over 3 months
8)Written informed consent
Key exclusion criteria 1)Overt infection
2)Febrile state (over 38 degree C)
3)Severe complicaiton including heart disease, pulmonary fibrosis, bleeding tendency, uncontrollable hypertension and diabetes mellitus
4)Double cancer
5)Symptomatic brain metastasis
6)Uncontrolled third-space fluid retention
7)Pericardial effusion
8)varicella virus infection
9)Peripheral neuropathy
10)Hypersensitivity drug reaction
11)Pregnant and nursing woman
12)Inappropriate to entry by physician
Target sample size 88

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakanishi
Organization Kyushu University, Graduate School of Medical Sciences
Division name Research Institute for Diseases of the Chest
Zip code
Address 3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL 092-642-5378
Email yoichi@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taishi Harada
Organization Kyushu University, Graduate School of Medical Sciences
Division name Research Institute for Diseases of the Chest
Zip code
Address 3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL 092-642-5378
Homepage URL
Email harada-t@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Lung Oncology Group in Kyushu, Japan (LOGIK)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立病院機構沖縄病院(沖縄県)
新日鐵八幡記念病院(福岡県)
福岡大学(福岡県)
九州医療センター(福岡県)
今給黎総合病院(鹿児島県)
国立病院機構南九州病院(鹿児島県)
福岡東医療センター(福岡県)
国立病院機構大牟田病院(福岡県)
九州大学(福岡県)
長崎大学(長崎大学)
浜の町病院(福岡県)
九州厚生年金病院(福岡県)
済生会福岡総合病院(福岡県)
北九州市立医療センター(福岡県)
春回会 井上病院(長崎大学)
琉球大学(沖縄県)
鹿児島大学(鹿児島県)
飯塚病院(福岡県)
久留米大学(福岡県)
福岡大学筑紫病院(福岡県)
佐賀大学(佐賀県)
熊本大学(熊本県)
新別府病院(大分県)
大分県立病院(大分県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
国立病院機構都城病院(宮崎県)
藤元早鈴病院(宮崎県)
熊本中央病院(熊本県)
北部地区医師会病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 14 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 No longer recruiting
Date of protocol fixation
2008 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2012 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
2010 Year 10 Month 14 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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