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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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