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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011391
Receipt No. R000013341
Scientific Title Phase3 study of docetaxel/TS-1 versus docetaxel in patients with previously treated non-small cell lung cancer
Date of disclosure of the study information 2013/08/07
Last modified on 2016/08/09

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Basic information
Public title Phase3 study of docetaxel/TS-1 versus docetaxel in patients with previously treated non-small cell lung cancer
Acronym KRSG-1301
Scientific Title Phase3 study of docetaxel/TS-1 versus docetaxel in patients with previously treated non-small cell lung cancer
Scientific Title:Acronym KRSG-1301
Region
Japan

Condition
Condition Non-small cell lung cancer patients with postoperative recurrence or stage3-4 with chemotherapy treatment history
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 As a treatment for secondary treatment and later for non-small cell lung cancer patients treated with DTX monotherapy and TS-1 combination therapy and DTX, I compare the progression free survival (PFS) .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes progression free survival (PFS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 docetaxel 35mg/m2 biweekly + TS-1 80-120mg/day from day1 to day 7 in two weeks
Interventions/Control_2 docetaxel 60mg/2 triweekly
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with histological diagnosis has been diagnosed with non-small cell lung cancer or in cytology
2)Non-small cell lung cancer of unresectable, cases of Stage 3B or 4 Stage or radical irradiation is not possible
3)Patients with measurable disease
4)Chemotherapy treatment history are cases of one regimen over the previous
5)It has passed more than 4 weeks if the four days or more chemotherapy if due to molecular targeted agents before, more than two weeks if UFT, an anti-tumor agent of the other is being used
6)Performance status(ECOG) is 0-2
7)Age of patients over 20 years old
8)Cases survival of 3 months or more is expected
9)Cases (bone marrow, lung, liver, and kidney) function has been held sufficient major organs
Key exclusion criteria 1)Patients with severe infection is suspected or there is fever cases are complicated by severe infection
2)Cases where there is intention or possibility pregnant women, pregnancy and breast-feeding
3)Patients having double cancer of activity of simultaneity, and multiple cancer or metachronous
4)Patients with severe drug allergy
5)Cases of bleeding (hemorrhagic enteritis, ischemic colitis, necrotizing enterocolitis) and gastrointestinal ulceration
6)Cases is determined pulmonary fibrosis or interstitial pneumonia is a problem in clinical CT images from
7)Cases are complicated by lung disease emphysema of advanced, chronic bronchitis severe, such as bronchial asthma
8)Cases with pleural effusion in need of treatment of drainage, etc., and storage of pericardial effusion
9)Brain metastasis of symptomatic
10)Patients with a myocardial infarction within 3 months after onset (diabetes that is difficult to control, liver damage (cirrhosis), renal failure, angina, and arrhythmia) and serious complication
119Patients with a history of administration TS-1 or DTX before treatment
12)Case it is determined to be inappropriate other attending physician to safely performed this study
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kunihiko kobayashi
Organization Saitama medical university international medical center
Division name Respiratory medicine
Zip code
Address 1397-1,Yamane Hidakashi Saitamaken
TEL 042-984-4667
Email kobakuni@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kunihiko kobayashi
Organization Saitama medical university international medical center
Division name Respiratory medicine
Zip code
Address 1397-1,Yamane Hidakashi Saitamaken
TEL 042-984-4111
Homepage URL
Email kobakuni@saitama-med.ac.jp

Sponsor
Institute Kanto respiratory disease study group
Institute
Department

Funding Source
Organization Kanto respiratory disease study group
Organization
Division
Category of Funding Organization Other
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
2013 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Terminated
Date of protocol fixation
2013 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 06 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013341

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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