UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000135
Receipt number R000000200
Scientific Title A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Date of disclosure of the study information 2005/09/08
Last modified on 2018/10/03 13:59:17

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy, toxicity, and survival of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate(according to RECIST criteria)

Key secondary outcomes

Median survival time, 1-year survival,
Adverse events, Time to Progression, 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

The treatment schedule included carboplatin AUC 4 on day 1, and gemcitabine 1000 mg/ m2 on days 1 and 8, every 3 weeks. (Below six courses more than three courses.)

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 with histologic or cytologic confirmation of locally advanced or metastatic NSCLC
2)Received either no prior chemotherapy were eligible
3)Measurable lesions
4)Age ≥ 70;
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
6)Adequate organ function
7)Life expectancy for more than 3 months
8)Written informed consent

Key exclusion criteria

1)After thoracic irradiation
2)A case having severe infection and a serious complication
3)Requiring treatment pleural/ascites /pericardial effusion,
4)Interstitial pneumonia or active lung fibrosis on chest X-ray,
5)Symptomatic brain metastases
6)Double cancer
7)Others

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Katakami

Organization

Institute of Biomedical Research and Innovation

Division name

Department of Translational Research Division of Integrated Oncology

Zip code


Address

2-2,Minatojima-Minamimachi,Chuo-ku,Kobe 650-0047 Japan

TEL

078-304-5200

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takashi Nishimura

Organization

Kobe City General Hospital

Division name

Respiratory Medicine

Zip code


Address

4-6,Minatojima-Nakamachi,Chuo-ku,Kobe 650-0046 Japan

TEL

078-302-4321

Homepage URL


Email

t-nishi@kcgh.gr.jp


Sponsor or person

Institute

Institute of Biomedical Research and Innovation

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 09 Month 08 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

2004 Year 12 Month 17 Day

Date of IRB


Anticipated trial start date

2005 Year 03 Month 01 Day

Last follow-up date

2012 Year 01 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 09 Month 08 Day

Last modified on

2018 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name