UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000547 |
|---|---|
| Receipt number | 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 16:44:29 |
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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
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
mio@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Thoracic Oncology Research Group (KTORG)
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000557
