UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003676 |
|---|---|
| Receipt number | R000004125 |
| Scientific Title | Maintenance TS-1 for advanced non-small cell lung cancer: a phase 2 study |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2020/12/01 14:11:09 |
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Basic information
Public title
Maintenance TS-1 for advanced non-small cell lung cancer: a phase 2 study
Acronym
Maintenance TS-1
Scientific Title
Maintenance TS-1 for advanced non-small cell lung cancer: a phase 2 study
Scientific Title:Acronym
Maintenance TS-1
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of maintenance TS-1 in advanced non-small cell lung cancer patients who achieved any response after platinum-doublet chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to treatment failure
Key secondary outcomes
Rate of adverse events, progression-free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Maintenance TS-1
Interventions/Control_2
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) pathologically diagnosed non-small cell lung cancer patients
2) clinically stage IV (UICC, 7th edition)
3) CR, PR, or SD was achieved after prior platinum-doublet chemotherapy
4) No history of chemotherapy other than lung cancer, and radiotherapy of primary lung lesion
5) ECOG PS 0-1
6) Good major organ function
7) Written informed consent by patient
Key exclusion criteria
1) active multiple malignancy
2) infection, ileus, vomiting
3) history of hemoptysis
4) history of thrombotic or hemorrhagic
disorders
5) tumor invasion to major thoracic vessel
6) tumor cavitation
7) nonhealing bone fracture
8) uncontrolled digestive ulcer
9) uncontrolled hypertension
10) interstitial pneumonia
11) pregnancy or lactation
12) symptomatic brain metastasis
13) severe drug allergy
3)-6) was excluded only in patients who received bevacizumab-containing first-line chemotherapy.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ohe |
Organization
National Cancer Research Center Hospital East
Division name
Division of thoracic oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa
TEL
04-7133-1111
yohe@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Niho |
Organization
National Cancer Research Center Hospital East
Division name
Division of thoracic oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
siniho@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Research Hospital East
Institute
Department
Personal name
Funding Source
Organization
a grant in aid for Cancer research from the Ministry of Health and Welfare, Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2010 | Year | 05 | Month | 31 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004125
