UMIN-CTR Clinical Trial

Public title

Gemcitabine / Docetaxel combination chemotherapy for non-small cell lung cancer patient of safety confirmation test research

Acronym

Safety test on GEM/DOC combination chemotherapy to NSCLC

Scientific Title

Gemcitabine / Docetaxel combination chemotherapy for non-small cell lung cancer patient of safety confirmation test research

Scientific Title:Acronym

Safety test on GEM/DOC combination chemotherapy to NSCLC

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Gemcitabine/Docetaxel combination chemotherapy for non-small cell lung cancer patient and confirmation of safety

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

safety

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Gemcitabine / Docetaxel

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.The example of treating Mi in the non-small cell lung cancer and patients who obtained the conviction according to the cytology the organization and looking after cannot excision patient who has untreated disease and recurrent disease
2.Case of PS 0-2
3.Patient of Omoats abnormality of hepatic function and kidney function who not is
(a)Cr<1.5mg/dl, Ccr>50ml/min
(b)T.Bil<2.0mg/dl,GOT,GPT<2xupper normal limit
4.The number of 4000 of the leukocyte count or more before it treats and the number of 2000 of neutrophil count or more, and the number of platelets is 100000 or more, and Hb 10.0/dl or more.
5.Case who obtained agreement by document
6.Have the change to a morbid state that can be measured or can evaluated for the survival time of three months
More to be expected more than administering beginning day.

Key exclusion criteria

1.It a large amount is pericardial fluid with the subjective symptom is does pleural effusion or is a patient who admits as for the peritoneal fluid.
2.Patient with bone metastasis and brain metastasis focus where vena cava superior syndrome and pain are strong to need radiotherapy in emergency
3.It is a patient from whom the having infectious disease is doubted as for the patient and generation of heat that has the infectious disease.
4.It is a patient who has as for the syndrome of complication.
5.Patient who has clear tip neurological symptom (However, the one that originates in an original disease is excluded).
6.Patient who has the past of clear medicine hypersensitivity to treatment
7.Case from whom interstitial pneumonia or fibroid lung clear because of simple X rays of chest is admitted
8.Patient who has pregnant woman or possibility of pregnancy
Case who judged that physician in charge is improper to this treatment object

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	yosida kazuo

Organization

Shinshu University School of Medicine

Division name

Department of Respiratory organ surgery

Zip code

Address

Asahi 3-1-1,Matsumoto,Nagano,390-8621,Japan

TEL

0263-37-2657

Email

Name of contact person

1st name
Middle name
Last name	yosida kazuo

Organization

Shinshu University School of Medicine

Division name

Department of Respiratory organ surgery

Zip code

Address

Matsumoto,Nagano,390-8621,Japan

TEL

0263-37-2657

Homepage URL

Email

Institute

Nagano Prefecture lung cancer chemotherapy Study Group

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2005

Year

03

Month

22

Day

Date of IRB

Anticipated trial start date

2005

Year

03

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 related information

Registered date

2005

Year

08

Month

31

Day

Last modified on

2005

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=R000000147