UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000072
Receipt number R000000119
Scientific Title A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer
Date of disclosure of the study information 2005/08/22
Last modified on 2015/08/31 15:30:33

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Basic information

Public title

A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

Acronym

A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

Scientific Title

A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

Scientific Title:Acronym

A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

Region

Japan


Condition

Condition

previously untreated elderly non-small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To establish the toxicities and maximum tolerated dose (MTD) of gemcitabine with carboplatin, and to determine the recommended dose (RD) for previously untreated elderly non-small cell lung cancer (NSCLC).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

to establish MTD and to determine the RD

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

The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 1, and gemcitabine with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 and 8, every 3 weeks.

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

Patients with histologic or cytologic confirmation of locally advanced or metastatic NSCLC who received either no prior chemotherapy were eligible.
The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 70; (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; (4) adequate organ function

Key exclusion criteria

The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayasu Kurata

Organization

Hyogo Medical Center for Adults

Division name

Department of Medical Oncology

Zip code


Address

13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558

TEL

078-929-1151

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address


TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

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

2005 Year 08 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=22306126

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

2005 Year 03 Month 26 Day

Date of IRB


Anticipated trial start date

2005 Year 06 Month 01 Day

Last follow-up date

2008 Year 06 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

2005 Year 08 Month 22 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name