UMIN-CTR Clinical Trial

Public title

A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer

Acronym

Maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin

Scientific Title

A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer

Scientific Title:Acronym

Maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin

Region

Japan

Condition

advanced non-small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this study is to compare the efficacy and safety of pemetrexed to those of docetaxel as maintenance therapy in patients without progressive disease after receiving treatment with pemetrexed plus carboplatin

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

survival without grade 3/4 toxicity

Key secondary outcomes

response rate, overall survival, progression free survival, safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients were included in the run-in phase (four cycles of carboplatin plus pemetrexed).The end of the run-in phase, patients who did not have progressive disease were randomly allocated to pemetrexed.

Interventions/Control_2

Patients were included in the run-in phase (four cycles of carboplatin plus pemetrexed).The end of the run-in phase, patients who did not have progressive disease were randomly allocated to docetaxel.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

All participants must meet the following criterias
1: Histologically or pathologically proven NSCLC
2: Radiographically measurable lesion
3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4: Stage 3B/4 NSCLC
5: Age more than 20 years and less than 75 years
6:
Neutrophil count: more than 1,500/uL
Platelet count: more than 100,000/uL
Hemoglobin: more than 9.0 g/dL
Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range
Total bilirubin: less than 1.5mg/dL.
PaO2: more than 60 torr
Creatinine: less than 1.2mg/dL or a calculated creatinine clearance more than 45 mL/min
7: Life expectancy of more than 12 weeks
8: Written informed consent

Key exclusion criteria

Exclusion criterias are as follows
1: Squamous cell carcinoma
2: Active interstitial pneumonia identified by chest X-ray
3: Uncontrolled massive pleural effusion or cardiac effusion
4: Superior vena cava syndrome
5: Uncontrolled brain metastases
6: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 12 months
7: Severe infection
8: Pregnancy or lactation
9: Active concomitant malignancy
10: History of severe allergic reactions to drugs
11: Severe and unstable medical comorbidities
12: Judgment to attending physician

Target sample size

84

Name of lead principal investigator

1st name
Middle name
Last name	Kingo Chida

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama Hamamatsu Shizuoka 431-3192 Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Naoki inui

Organization

Hamamatsu University School of Medicine

Division name

Clinical Pharmacology and Therapeutics

Zip code

Address

TEL

Homepage URL

Email

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Self funding

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

浜松医科大学附属病院（静岡県）

Date of disclosure of the study information

2010

Year

08

Month

31

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

Completed

Date of protocol fixation

2010

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

20

Day

Last modified on

2012

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004905