UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004866
Receipt number R000005793
Scientific Title Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Date of disclosure of the study information 2011/01/14
Last modified on 2019/01/21 18:23:12

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Basic information

Public title

Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer

Acronym

Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer

Scientific Title

Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer

Scientific Title:Acronym

Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer

Region

Japan


Condition

Condition

non small and non squamous lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

feasibility study

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

feasibility study (4 courses)

Key secondary outcomes

1-year recurrence-free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pemetrexed, Carboplatin

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Initial chemottherapy
2.ECOG performance status0-1
3.Stage IIor III after complete resection
4.Age of 20 years or older
5.Laboratory parameters obtained before registation
WBC count:>4000/uL, <12000/uL
neutrophil count:>2000/uL
Platelet count:>10*10000/uL
Hemoglobin:>9.5g/dL
GOT,GPT:<100 IU/L
Total bilirubin:<2.0mg/dL
PaO2:>60 torr
creatinine:<1.5mg/dL
6.Anticipated life expectancy of at least 3 months
7.Capable to registrate in 30days after surgery
8.Capable to stay in the hospital
9.Obtained informed consent

Key exclusion criteria

1.Interstitial pneumonia or pulmonary fibrosis on Chest Xray
2.Unstable pleural effusion formation
3.Superior vena cava syndrome
4.Uncotrolled diabetes mellitus, hypertension, liver dysfunction, angina pectoris, and acute myocardial infarction
5.Severe infection, a sign of severe infection
6.Grade2 or worse peripheral nerve disorder at the time of enrollment
7.Regular user of NSAIDs
8.Pregnant woman, lactating woman, woman of child-bearing potential, woman who wish to pregnancy
9.Severe drug allergy
10.Severe complication
11Other inadequate reasons
12.New lesion that is recognized before enrollment

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuaki Sakai

Organization

University of Tsukuba

Division name

Department of Thoracic Surgery

Zip code


Address

1-1-1 Tennoudai, Tsukuba, Japan

TEL

029-853-3097

Email

misakai@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuaki Sakai

Organization

University of Tsukuba

Division name

Department of Thoracic Surgery

Zip code


Address

1-1-1Tennoudai, Tsukuba, Japan

TEL

029-853-3097

Homepage URL

http://www.md.tsukuba.ac.jp/

Email

misakai@md.tsukuba.ac.jp


Sponsor or person

Institute

Department of Thoracic Surgery,
University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Department of Thoracic Surgery,
University of Tsukuba

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

2011 Year 01 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://jlcs55.umin.jp/program.html

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

No longer recruiting

Date of protocol fixation

2009 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2015 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 01 Month 13 Day

Last modified on

2019 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name