UMIN-CTR Clinical Trial

Public title

A randomized phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in patients with chemotherapy naïve non-squamous non-small cell lung cancer.

Acronym

A randomized phase II study of PEM+CBDCA followed by PEM versus PTX+CBDCA followed by PEM in patients with non-squamous NSCLC.

Scientific Title

A randomized phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in patients with chemotherapy naïve non-squamous non-small cell lung cancer.

Scientific Title:Acronym

A randomized phase II study of PEM+CBDCA followed by PEM versus PTX+CBDCA followed by PEM in patients with non-squamous NSCLC.

Region

Japan

Condition

Chemotherapy naïve non-squamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate and compare the efficacy and safety of PEM+CBDCA followed by PEM and PTX+CBDCA followed by PEM in patients with non-squamous NSCLC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression Free Survival

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pemetrexed(PEM)500mg/m2 Day1, Carboplatin(CBDCA)AUC6 Day1 q3week*3cycles
Maintenance Pemetrexed(PEM)500mg/m2 Day1 q3week*more than 4cycles until PD

Interventions/Control_2

Paclitaxel(PAC)200mg/m2 Day1, Carboplatin(CBDCA) AUC6 Day1 q3week*3cycles
Maintenance Pemetrexed(PEM)500mg/m2 Day1 q3week*more than 4cycles until PD

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Written informed consent.
Chemotherapy-naive patients with histologically or cytologically confirmed non-squamous non-small cell lung cancer.
Patients aged 20 years or older.
ECOG performance status of 0-1.
Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
WBC>=4,000/mm3, <=12,000/mm3
Plt>= 100,000/mm3
Hb >= 10g/dl
AST and ALT, *2 of upper limit of normal(ULN)or less.
T-Bil <= 1.5mg/d
Cre <= 1.5mg/dl
creatinine clearance>=60ml/min
PaO2 >= 60Torr Life expectancy over 3 months

Key exclusion criteria

Severe complicaiton including heart disease, pulmonary fibrosis, bleeding tendency,
uncontrollable hypertension and diabetes mellitus.
Patients with symptomatic brain metastasis.
Active concomitant malignancy.
Past history of drug hypersensitivity.
Psychiatric disorder.
Systemic steroid administration.

Target sample size

140

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Takayama

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

Email

koichi-t@kokyu.med.kyushu-u.ac.jp

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

Email

harada-t@kokyu.med.kyushu-u.ac.jp

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北九州市立医療センター（福岡県）
九州大学（福岡県）
熊本大学（熊本県）
国立病院機構大牟田病院（福岡県）
国立病院機構沖縄病院（沖縄県）
国立病院機構熊本医療センター（熊本県）
国立病院機構熊本再春荘病院（熊本県）
国立病院機構福岡東医療センター（福岡県）
済生会福岡総合病院（福岡県）
済生会二日市病院（福岡県）
佐賀県立病院好生館（佐賀県）
佐賀大学（佐賀県）
産業医科大学（福岡県）
社会保険大牟田天領病院（福岡県）
仁愛会浦添総合病院（沖縄県）
新日鐵八幡記念病院（福岡県）
新別府病院（大分県）
聖マリア病院（福岡県）
川内市医師会立市民病院（鹿児島県）
天神会新古賀病院（福岡県）
長崎市立市民病院（長崎県）
長崎大学（長崎県）
浜の町病院（福岡県）
福岡大学（福岡県）
九州厚生年金病院（福岡県）
飯塚病院（福岡県）
春回会 井上病院（長崎県）
済生会福岡第二病院（福岡県）
福岡大学筑紫病院（福岡県）
久留米大学（福岡県）

Date of disclosure of the study information

2011

Year

02

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2009

Year

12

Month

15

Day

Date of IRB

Anticipated trial start date

2010

Year

07

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

02

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=R000005952