UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005583
Receipt number R000006602
Scientific Title Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer
Date of disclosure of the study information 2011/05/11
Last modified on 2013/05/10 17:17:03

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Basic information

Public title

Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer

Acronym

Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer

Scientific Title

Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer

Scientific Title:Acronym

Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer

Region

Japan


Condition

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy and safety of the combination of Carboplatin and Pemetrexed with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Overall survival
Safety
Progression 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

Carboplatin+Pemetrexed

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Histologically confirmed Stage 3B/4 non-small-cell lung cancer and non-squamous cell carcinoma.
2.No prior chemotherapy.
3.With one or more measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver1.1
4.Age 20<=, <=75
5.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
6.Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function.
7.A life expectancy of more than 3 months.
8.All patients provided written informed consent before initiation of study-related procedures.

Key exclusion criteria

1.Symptomatic Brain metastasis.
2.History of active double cancer.
3.Severe infection
4.Severe comorbidity (heart failure tendency to hemorrhages, uncontrollable hypertension, uncontrollable diabetes, etc)
5.Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
6.With a history of drug sensitivity.
7.Pregnant or lactating women or those who declined contraception.
8.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Mori

Organization

Tochigi Cancer Center

Division name

Division of Thoracic Oncology

Zip code


Address

4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834

TEL

028-658-5151

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takashi Kasai

Organization

Tochigi Cancer Center

Division name

Division of Thoracic Oncology

Zip code


Address


TEL


Homepage URL


Email

takasai@tcc.pref.tochigi.lg.jp


Sponsor or person

Institute

Tochigi Cancer Center

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

2011 Year 05 Month 11 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

Completed

Date of protocol fixation

2009 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2009 Year 11 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

2011 Year 05 Month 10 Day

Last modified on

2013 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name