UMIN-CTR Clinical Trial

Public title

Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

Acronym

Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

Scientific Title

Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

Scientific Title:Acronym

Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

Region

Japan

Condition

Non-small cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate whether combination regimen of Docetaxel and Gemcitabine provides better overall survival than Docetaxel alone in patients with previously treated NSCLC

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Overall survival

Key secondary outcomes

Adverse events
Progression-free survival

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel alone

Interventions/Control_2

Docetaxel and Gemcitabine

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

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically and/or cytologically proven NSCLC
2) Advanced Stage (IV or IIIB)
3) One prior platinum-based chemotherapy
4) Excluded either docetaxel or gemcitabine
5) Age: 20 to 75
6) PS (ECOG scale): 0, 1
7) Adequate organ function
8) WBC>=4,000 /mm3, ANC>=2,000 /mm3, Hb>=9.5 g/dL, PLT>=100,000 /mm3
9) AST/ALT <=2.5 x Normal Upper Limit, T-Bil <= 1.5 mg/dL
10) Creatinine <= 1.2 mg/dL
11) PaO2 >=70 mmHg (Room air)
12) Written informed consent

Key exclusion criteria

1) Symptomatic brain metastasis
2) Double cancer
3) Superior vena cava syndrom
4) Massive pleural effusion or ascitis
5) Spiral compression
6) Severe hypertension
7) Diabetis melitus treated with insulin
8) Concommitant infectious disease excluded hepatic fever
9) Interstitial lung disease
10) Hypersinsitivity to Polysorbate 80
11) Need to treatment with steroid, ketoconazole, nifedipine or erithromycin
12) Psycologic illness
13) Women during pregbnancy or lacteted

Target sample size

284

Name of lead principal investigator

1st name
Middle name
Last name	Shunichi Negoro, MD

Organization

Osaka City General Hospital

Division name

Department of Plumonay Medicine

Zip code

Address

2-13-22Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Koji Takeda, MD

Organization

JCOG0104 Coordinating Office

Division name

Department of Plumonay Medicine, Osaka City General Hospital

Zip code

Address

2-13-22Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 JAPAN

TEL

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

国立病院機構北海道がんセンター(北海道）
旭川医科大学(北海道）
茨城県立中央病院・茨城県立地域がんセンター（茨城県）
栃木県立がんセンター（栃木県）
国立病院機構西群馬病院（群馬県）
群馬県立がんセンター（群馬県）
埼玉県立がんセンター（埼玉県）
国立がんセンター東病院（千葉県）
国立がんセンター中央病院（東京都）
都立駒込病院（東京都）
国立国際医療センター（東京都）
癌研究会附属病院（東京都）
虎の門病院（東京都）
神奈川県立がんセンター（神奈川県）
横浜市立市民病院（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
岐阜市民病院（岐阜県）
愛知県がんセンター（愛知県）
国立病院機構名古屋医療センター（愛知県）
県立愛知病院（愛知県）
大阪市立大学医学部（大阪府）
近畿大学医学部（大阪府）
大阪府立成人病センター（大阪府）
大阪府立呼吸器・アレルギー医療センター（大阪府）
国立病院機構近畿中央胸部疾患センター（大阪府）
国立病院機構刀根山病院（大阪府）
大阪府立病院（大阪府）
大阪市立総合医療センター（大阪府）
神戸市立中央市民病院（兵庫県）
兵庫医科大学（兵庫県）
兵庫県立成人病センター（兵庫県）
国立病院機構四国がんセンター（愛媛県）
九州大学病院（福岡県）
長崎大学医学部・歯学部附属病院（長崎県）
熊本地域医療センター（熊本県）

Date of disclosure of the study information

2005

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/19164456

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Terminated

Date of protocol fixation

2001

Year

11

Month

16

Day

Date of IRB

Anticipated trial start date

2002

Year

01

Month

01

Day

Last follow-up date

2004

Year

06

Month

01

Day

Date of closure to data entry

2005

Year

01

Month

01

Day

Date trial data considered complete

2005

Year

01

Month

01

Day

Date analysis concluded

2005

Year

03

Month

01

Day

Other related information

Registered date

2005

Year

07

Month

22

Day

Last modified on

2014

Year

02

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000060