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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002420
Receipt No. R000002965
Scientific Title A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Date of disclosure of the study information 2009/09/10
Last modified on 2018/09/18

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Basic information
Public title A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Acronym A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Scientific Title A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Scientific Title:Acronym A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Endocrinology and Metabolism Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of TS-1+Cisplatin or Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2 year survival rate
Key secondary outcomes Over all survival, Progression free survival, Compliance rate of protocol regimen, Adverse event

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 TS-1+Cisplatin+ radiation
Interventions/Control_2 VNR+ Cisplatin+ radiation
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 -Histologically or cytologically confirmed NSCLC
-No prior chemotherapy, radiotherapy or surgery (Open biopsy is allowed).
-Unresectable lung cancer Stage 3A
or 3B.
-V20 <= 35%
-Oral intake is possible
-Adult patients (>=20,<75 years of age)
-ECOG performance status 0 or 1
-Adequate organ function.
-Laboratory values must be as follows;
WBC count >= 4,000/mm3,
Neutrophil count >= 2,000/mm3
hemoglobin >= 9.5g/dL,
Platelet count >= 100,000/mm3
AST and ALT <= 100IU/LBilirubine level <= 1.5 mg/dL,
Serum creatinine <= 1.5 mg/dL
Creatinine clearance >= 60 mL/min,
PaO2 >= 70 torr
-Patients must sign an informed consent.
Key exclusion criteria -T3N1
-SVC syndrome.
-Clinically significant pleural or
pericardial effusion,Contralateral
Hilar lymph node metastasis,
-Patients with concurrent serious
infections or complications
-Continuous watery diarrhea
-Paralysis of the intestine, or ileus
-Significant interstitial pneumonitis
,pulmonary fibrosis or severe emphysema
in Chest Xp
-The presence of other concomitant cancers
-Concomitant therapy with another
new anticancer drug, phenytoin,
warfarin or flucytocine
-Inadequately controlled diabetes
mellitus
-HBs Ag is positive
-A history of serious drug allergy
-Mental disease or psychotic
manifestation
-Pregnancy,breast feeding or wish of
future bearing
-Other conditions not suitable for this
study
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonari Sasaki
Organization Graduate School of Medical Sciences Kyushu University
Division name Department of Radiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5378
Email tomonari@radiol.med.kyushu-u.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.3F 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 TAIHO PHARMACEUTICAL CO.,LTD
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 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30206369
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 05 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 09 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 09 Month 01 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002965

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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