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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025932
Receipt No. 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

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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
Email 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
Email umeda@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029815

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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