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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002015
Receipt No. R000002456
Scientific Title Randomized phase III study of nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung
Date of disclosure of the study information 2009/06/30
Last modified on 2015/11/06

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Basic information
Public title Randomized phase III study of
nedaplatin plus docetaxel versus
cisplatin plus docetaxel
for advanced or relapsed squamous cell carcinoma of the lung
Acronym Randomized phase III study of
nedaplatin plus docetaxel versus
cisplatin plus docetaxel
for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L)
Scientific Title Randomized phase III study of
nedaplatin plus docetaxel versus
cisplatin plus docetaxel
for advanced or relapsed squamous cell carcinoma of the lung
Scientific Title:Acronym Randomized phase III study of
nedaplatin plus docetaxel versus
cisplatin plus docetaxel
for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L)
Region
Japan

Condition
Condition squamous cell carcinoma of the lung
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the efficacy of nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression free survival, response rate and adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nedaplatin at 100mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered.
Interventions/Control_2 Cisplatin at 80mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered.
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Cytologically or histologically documented squamous cell carcinoma of the lung. Non-small-cell lung cancer with a predominant squamous component or adenosquamous carcinoma with a predominant squamous component are also acceptable.
2)Clinical stage IIIB, IV or postoperative recurrence, and unsuitable for radiotherapy.
3)Patient must have received no prior chemotherapy. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 1 year prior to recurrence of the disease.
4)ECOG performance status of 0 or 1.
5)>=20 and <75 years of age.
6)Radiographically-documented evaluable disease. Both measurable and non-measurable disease are permitted.
7)Expected survival of >= 3 months.
8)Adequate organ function.
9)Written informed consent.

Key exclusion criteria 1)Symptomatic brain metastasis or brain metastasis which needs treatment like adrenal corticosteroids or antiepileptic drugs.
2)Other current active malignancy.
3)Superior vena cava syndrome.
4)Malignant pericardial/ pleural/ peritoneal effusion which need continuous drainage or rapidly increase after temporary drainage.
5)Patient has received radiotherapy to the primary lesion.
6)Patient received palliative radiotherapy except to the primary lesion in last 2 weeks.
7)Patient has a clinically significant con current illness.
8)Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray.
9)Pregnant or breast-feeding woman or patient who doesn't agree to contraception.
10)Patient has a history of severe allergy or hypersensitivity.
11)Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study.
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-chou, Suntou-gun, Shizuoka, 411-8777, Japan
TEL 055-989-5222
Email nbyamamo@wakayama-med.ac.jp

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 Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization sanofi-aventis K.K
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 06 Month 30 Day

Related information
URL releasing protocol http://www.wjog.org/member/member_only/dlProtocol.php
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26522337
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
2009 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 07 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
2009 Year 05 Month 29 Day
Last modified on
2015 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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