UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008252
Receipt number	R000009728
Scientific Title	RCT PhaseII trial of Paclitaxel (P) and Carboplatin (C) plus continuous Gemcitabine (G) versus Gemcitabine (G) and Carboplatin (C) plus continuous Gemcitabine in untreated non-small cell lung cancer (NSCLC)
Date of disclosure of the study information	2012/06/25
Last modified on	2012/08/27 22:13:20

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Basic information

Public title

RCT PhaseII trial of Paclitaxel (P) and Carboplatin (C) plus continuous Gemcitabine (G) versus Gemcitabine (G) and Carboplatin (C) plus continuous Gemcitabine in untreated non-small cell lung cancer (NSCLC)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Compare the safety and usefulness, and the primary endpoint group maintenance therapy, the survival benefit of each successive + gemcitabine combination gemcitabine + carboplatin group and the maintenance therapy sequential + gemcitabine combination paclitaxel + carboplatin for non-small cell lung cancer stage three B / four untreated to select the investigational arm of phase three trial for the study, to clarify the clinical significance of sequential maintenance therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Progression Free Survival: PFS

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Three cycles of Pacritaxel+ Carboplatin followed by maintenance Gemcitabine in 21-day cycles until progression disease

Interventions/Control_2

Three cycles of Gemcitabine+Carboplatin followed by maintenance Gemcitabine in 21-day cycles until progression disease

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients
2) Ptients who have measurable lesion or evaluable lesion by RECIST
3) Stage three/four without any indications for radiotherapy
4) Patients aged from 20 to 75years older 5)ECOG PS 0-1
6) Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as
WBC >= 4,000/mm3
Neu >= 1,500/mm3
Plt >= 100,000/mm3
Hb >= 10 g/dL
AST/ALT <=100IU/L
T.Bil <= 1.5 g/dL
Ccr >=60mL/min, sCr: x 1.2 of upper limit of normal or less.
SpO2 >= 95% as room air
7)Patients are excepted to live over 3 months after administration day.
8)Written informed consent from the patients

Key exclusion criteria

1)Having the bleeding tendency which is clear in clinic
2)An agreement is not obtained for support therapy such as transfusion etc
3)Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
4) History of severe heart disease (uncontrollable arrythmia, uncontrollable angina pectoris, congestive heart failue, etc within 6 months)
5)Patients with jaundice
6)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
7)Patiens has pleural effusion, pericardial effusion and ascites to need treatment for
8)Acute inflammatory disease
9)Uncontrollable diabetes mellitus and hypertenson
10)Patients with mental disorders seems to be in need of treatment or during treatment with psychotropic drugs
11)Sub-cases considered severe intestinal obstruction, or intestinal obstruction clinically
12)Patients with complications considered serious to interfere with the performance of treatment
13)Patients with suspected infection
14)Patients with a history of hypersensitivity to (such as cyclosporine injection)-containing preparations (Kuremohoru EL ®) polyoxyethylene castor oil
15)Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity
16)Patients with brain metastases with the clinical symptoms
17) Patients who underwent radiation therapy to the lesions can be evaluated
18) The patient has drug allergies
19)Serious Patients with) will (possibly during pregnancy and pregnancy or lactating
20) principal investigator cases that are deemed inappropriate

Target sample size

100

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takashi Kijima

Organization

Osaka University Hospital

Division name

Respiratory

Zip code

Address

15, 2 Yamadaoka, Suita, Osaka

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name

Organization

Osaka University Hospital

Division name

Respiratory

Zip code

Address

TEL

Homepage URL

Email

Sponsor or person

Institute

Respiratory, Osaka University Hospital

Institute

Department

Personal name

Funding Source

Organization

Respiratory ,Osaka University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

OULCSG

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 25 Day

Related information

URL releasing protocol

Publication of results

Partially published

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

Completed

Date of protocol fixation

2007 Year 12 Month 10 Day

Date of IRB

Anticipated trial start date

2008 Year 02 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 06 Month 25 Day

Last modified on

2012 Year 08 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009728

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name