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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000547
Receipt No. R000000557
Scientific Title Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC).
Date of disclosure of the study information 2007/01/01
Last modified on 2011/06/08

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Basic information
Public title Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC).
Acronym Randomized phase II trial of dexmethasone as premedication to GEM and CBDCA
Scientific Title Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC).
Scientific Title:Acronym Randomized phase II trial of dexmethasone as premedication to GEM and CBDCA
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 efficacy of dexamethasone as a premediciton to
Gemcitabine and carboplatin combination therapy in patients with stage IIIB or IV non small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Dose reduction rate (DRR) in the second cycle
Key secondary outcomes Deferment rate (DR) of the second cycle
Objective Response Rate (ORR)
Time to progression (TTP)
Overall survival (OS)
Safety (Toxicity profile)
Platelet transfusion rate (PER)

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine(GEM):1000mg/m2 Day1,8
Carboplatin(CBDCA):AUC=4.5 Day1
Interventions/Control_2 Gemcitabine(GEM):1000mg/m2,Day1,8
Carboplatin(CBDCA):AUC=4.5,Day1
Dexamethasone(Dex) :8mg/body/day,Day-4.-3.-2.-1.0
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 1) Pathological confirmed Stage IIIB IV NSCLC without previous chemotherapy
2) Measurable lesions (RECIST)
3) Age: >=20 and <80
4) no indication for radiation therapy
5) ECOG Performance Status: 0 - 1
6) Sufficient organ functions defined as:
neutrophil >1500/mm3
Platelet 1000000/mm3
Hemoglobin >9.0gr/dl
AST/ALT : <2.5XULN of the instituion
serum T-bilirubin level<=1.5 mg/dl
serum creatinine level<=1.5 mg/dl
SpO2 >=95% (room air)
7) Expected survival over 3 months
8) Provided written informed consent

Key exclusion criteria 1)Clinically apparent interstitial pneumonia in chest X ray or CT
2)Pleural or pericardial effusion, or ascites requiring treatment
3)Treated Pericardial effusion or ascites
4)SVC syndrome
5)Brain metastasis requiring treatment
6)Patients with active concomitant cancer
7)Uncontrolled diabetes
8)Severe cardiovascular diseases
a.uncontrollable hypertension
b.congestive heart failure
c.unstable angina, myocardial infarction or PTCA/CAGB therapy within the past six months
d.uncontrollable arrythmias
9) Patients with liver cirrhosis
10) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
11) Medical history of serious allergic reactions to any drug
12)Active inflammatory diseases
13)Active or chronic infectious diseases (especially patients with positive HBs-Ag or active mycobacterial infection)
14) Regular use of steroids or immunosupressive drugs
15)Refusal to blood transfusion
16)Patient with known bleeding disorders
17) Inappropriate patients for this study judged by the physicians.
Target sample size 76

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi Nakatani
Organization National Hospital Organization Kyoto Medical Center
Division name Pulmonary Medicine
Zip code
Address 1-1Mukaihata, Fushimi-ku, Kyoto City, Japan
TEL 075-643-4325
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Mio
Organization Kyoto University
Division name Respiratory Medicine
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL 075-751-3830
Homepage URL https://www.kanazawa-univ-pharm.jp/ktorg/index.html
Email mio@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Thoracic Oncology Research Group (KTORG)
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
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

Other administrative information
Date of disclosure of the study information
2007 Year 01 Month 01 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
Date of protocol fixation
2006 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2008 Year 07 Month 01 Day
Date of closure to data entry
2008 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 12 Month 09 Day
Last modified on
2011 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000557

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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