UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000146
Receipt number R000000211
Scientific Title Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
Date of disclosure of the study information 2005/09/09
Last modified on 2014/12/04 17:54:53

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Basic information

Public title

Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)

Acronym

Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP)

Scientific Title

Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)

Scientific Title:Acronym

Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP)

Region

Japan


Condition

Condition

non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

Toxicity, Progression-free survival, Response rate, Symptom score


Base

Study type

Interventional


Study design

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


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel alone administered by 3 consecutive weekly infusions

Interventions/Control_2

Cispatin and docetaxel administered by 3 consecutive weekly infusions

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) histologically or cytologocally proven non-small-cell lung cancer
2) stage IV, or stage III disease ineligible for definitive radiotherapy
3) 70 years or older
4) ECOG PS 0-1
5) Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
6) No prior chemothrapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
7) No prior surgery within 4weeks before enrollment
8) No prior radiotherapy for primary tumor
9) No prior radiotherapy for metastatic lesions within 2weeks before enrollment
10) Adequate organ function
11) Signed informed consent

Key exclusion criteria

1) Symptomatic brain metastasis
2) Active another neoplams
3) Severe SVC syndrome
4) Massive pericardial, pleural effusion, or ascites
5) Bone metastasis emergent for palliative radiotherapy or surgery
6) Uncontrollable systemic hypertension
7) Heart failure, Unstable angina Myocardial infarction within 6 months
8) Uncontrollable diabetes
9) Active infection
10) Interstitial pneumonia/ Pulmonary fibrosis
11) Hypersensitivity for polysolbate 80
12) Systemic administartion of corticosteroids

Target sample size

230


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Yokoyama, MD, PhD

Organization

Niigata Cancer Center Hospital

Division name

Department of internal medicine

Zip code


Address

2-15-3 Kawagishi-cho, Niigata

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Tsukada, MD

Organization

JCOG0207 Coordinating Office

Division name

Department of internal medicine, Niigata Cancer Center Hospital

Zip code


Address

2-15-3 Kawagishi-cho, Niigata

TEL

025-266-5111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00190476

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

北海道がんセンター(北海道)
国立病院機構道北病院(北海道)
山形県立中央病院(山形県)
茨城県立中央病院(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)
国立国際医療センター(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(新潟県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
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)
近畿中央胸部疾患センター(大阪府)
刀根山病院(大阪府)
大阪市立総合医療センター(大阪府)
兵庫医科大学(兵庫県)
兵庫県立成人病センター(兵庫県)
四国がんセンター(愛媛県)
九州大学医学部附属病院(福岡県)
熊本地域医療センター(熊本県)


Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25378648

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2003 Year 03 Month 24 Day

Date of IRB


Anticipated trial start date

2003 Year 04 Month 01 Day

Last follow-up date

2007 Year 02 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 09 Day

Last modified on

2014 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000211


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name