UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002015 |
|---|---|
| Receipt number | 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 14:04:22 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002456
