UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001328
Receipt number R000001592
Scientific Title Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer
Date of disclosure of the study information 2008/08/23
Last modified on 2015/07/22 16:38:42

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Basic information

Public title

Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer

Acronym

Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer

Scientific Title

Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer

Scientific Title:Acronym

Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy of biweekly Paclitaxel + Carboplatin for the elderly patients older than 70years old with nonressectable non-small cell lung cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Response Rate

Key secondary outcomes



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

Paclitaxel and carboplatin are given on day1 and day15 every 28days.

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)Patients who were histologically or cytologically confirmed non-small cell lung cancer.
2)Patients who have measurable lesion.
3)No prior chemotherapy.
4)Stage IIIB or IV.
5)ECOG PS 0-2
6)Older than 70years old.
7)Patients who have adequate organ function.
WBC>=4000/mm3
neutrophil count>=2000/mm3
Platelet count>=100,000/mm3
Hemoglobin>=9.0g/dl
GOT,GPT within twice the upper limit of normal of institution
Serum creatinine <=1.5mg/dl
Normal ECG or UCG
8)Patients who have no severe complication.
9)Patients who have estimated life expectancy longer than 1 month.
10)Written informed consent.

Key exclusion criteria

1)Patients with severe heart disease.
2)Patients with recent history of myocardial infarction.
3)Patients with liver cirrhosis.
4)Patients with pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray.
5)Patients with severe diabetis mellitus.
6)Patients with ileus.
7)Patients with infection.
8)Patients with severe complications.
9)Patients with peripheral neuropathy.
10)Patients with severe mental disorder.
11)Patients with severe drug allergy.
12)Patients judged unfit to be enrolled in the study by the investigator .

Target sample size

65


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akitoshi Ishizaka

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine

Zip code


Address

35 Shinanomachi-Shinjuku

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine

Zip code


Address


TEL


Homepage URL


Email

hiroyukiyasuda@hotmail.com


Sponsor or person

Institute

Keio University School of Medicine Division of Pulmonary Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine Division of Pulmonary Medicine

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

2008 Year 08 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


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

2006 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 08 Month 20 Day

Last modified on

2015 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001592


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name