UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011391 |
|---|---|
| Receipt number | 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 19:44:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kobakuni@saitama-med.ac.jp
Sponsor or person
Institute
Kanto respiratory disease study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013341
