UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004386 |
|---|---|
| Receipt number | 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 10:16:41 |
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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
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
harada-t@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003754
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