UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004018
Receipt number R000004830
Scientific Title Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Date of disclosure of the study information 2010/08/10
Last modified on 2010/08/09 13:38:08

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Basic information

Public title

Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients

Acronym

Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients

Scientific Title

Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients

Scientific Title:Acronym

Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients

Region

Japan


Condition

Condition

Non-squamous non-small cell lung cancer in elderly chemo-naive patients

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of pemetrexed for chemo-naive non-squamous non-small cell lung cancer in elderly patients

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
Progression free survival
Safety
Quality of life


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 (500mg/m2) day 1,q3w until disease progression

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Chemo-naive clinical stage IIIB/IV or relapsed patients (no indication of surgery or radiotherapy)
3)Age of 70 years or older
4)Performance status(PS) of 0-1 in ECOG criteria
5)Adequate organ functions
6)With measurable lesion
7)Life expectancy more than 3 months
8)Written informed consent

Key exclusion criteria

1)Patients with brain metastasis in need of steroid or anticonvulsant
2)Previous radiation therapy to primary lesion
3)History of active double cancer
4)Patients with superior vena cava syndrome
5)Uncontrollable pleural effusion, pericardial effusion or ascites
6)History of uncontrollable hypertention, diabetes mellitus, active angina pectoris, active gastrointestinal hemorrhage, recent cardiac incompetence, recent myocardial infarction, and active virus infection(except viral hepatitis)
7)Interstitial pneumonia or pulmonary fibrosis obviously detectable on chest X-ray
8)History of severe drug allergy
9)History of severe psychiatric disease
10)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhisa Takahashi

Organization

Juntendo University, School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

2-1-1 Hongo,Bunkyo-Ku,Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Keiko Muraki

Organization

Juntendo University, School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

2-1-1 Hongo,Bunkyo-Ku,Tokyo

TEL

03-5802-1063

Homepage URL


Email



Sponsor or person

Institute

Juntendo University

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

2010 Year 08 Month 10 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

Open public recruiting

Date of protocol fixation

2010 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2010 Year 04 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

2010 Year 08 Month 09 Day

Last modified on

2010 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004830


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name