UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025932 |
|---|---|
| Receipt number | R000029815 |
| Scientific Title | The combination chemotherapy of carboplatin and TS-1 followed by the maintenance therapy of TS-1 in advanced non-small cell lung cancer. Phase 2 trial. |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2018/04/30 15:09:25 |
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Basic information
Public title
The combination chemotherapy of carboplatin and TS-1 followed by the maintenance therapy of TS-1 in advanced non-small cell lung cancer. Phase 2 trial.
Acronym
TS-1 plus CBDCA followed by TS-1 in advanced NSCLC
Scientific Title
The combination chemotherapy of carboplatin and TS-1 followed by the maintenance therapy of TS-1 in advanced non-small cell lung cancer. Phase 2 trial.
Scientific Title:Acronym
TS-1 plus CBDCA followed by TS-1 in advanced NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of TS-1 plus carboplatin followed by TS-1 for advanced non-small cell lung cancer in elderly patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival from the initiation of an induction chemotherapy, TS-1 plus CBDCA
Key secondary outcomes
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
A combination chemotherapy of TS-1 and carboplation followed by the maintenance therapy of 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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologacally or cytologically proven NSCLC
2) Stage 3B or 4
3) Patients who can take food orally
4) Presence of measurable lesions
5) Age 70-74, PS 2 or age 75 or over, PS0-1
Key exclusion criteria
1) Severe drug allergy
2) Uncontrolable effusion
3) Within 2 weeks after radiotherapy for lesions except primary lesion.
4) Continuous watery diarrhea
5) Active double cancer
6) EGFR mutation positive or ALK fusion gene positive non-squamous cell carcinoma
7) Severe complications
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka, M.D. |
Organization
University of Fukui Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
tamotsui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Umeda, M.D. |
Organization
University of Fukui Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Uninersity of Fukui
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
| 2017 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029815
