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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010593
Receipt No. R000012381
Scientific Title Feasibility study of S-1 alternate-day and Carboplatin in advanced or recurrent non- small cell lung cancer.
Date of disclosure of the study information 2013/04/25
Last modified on 2013/04/25

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Basic information
Public title Feasibility study of S-1 alternate-day and Carboplatin in advanced or recurrent non- small cell lung cancer.
Acronym Feasibility study of S-1 alternate-day and Carboplatin in advanced or recurrent NSCLC.
Scientific Title Feasibility study of S-1 alternate-day and Carboplatin in advanced or recurrent non- small cell lung cancer.
Scientific Title:Acronym Feasibility study of S-1 alternate-day and Carboplatin in advanced or recurrent NSCLC.
Region
Japan

Condition
Condition advanced or recurrent NSCLC
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of S-1 alternative-day and Carboplatin in advanced or recurrent NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes feasibility
Key secondary outcomes Progression free survival
Response Rate
Safety
Quality of life

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 80mg/m2/day(administration on Mon,Wed,Fri,Sun)
Carboplatin AUC5(every3weeks)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with pathologically proven non small cell lung cancer.
2)advanced or recurrent NSCLC.
3)Patients with no prior chemotherapy.
4)Age of 20 years or older.
5)ECOG Performance status:0-1
6)Sufficient oral intake.
7)Have adequate organ function within two week before study entry.
WBC>=4000/mm3
hemoglobin>=9.0g/dl
Platelets>=100000/mm3
Total bilirubin>=1.5mg/dl
Creatinine<=1.2mg/dl
Creatinine clearance>=60ml/min
AST,ALT<=100IU
PaO2>=60torr or SpO2>=90%
8)Patients with expected life for at 3 months
9)Written informed consent.
Key exclusion criteria 1) Patients with pleural or pericardial effusion ,or ascites.
2) Patients with active double cancer.
3)Patients with significant complications.
4)Patients with serious diarrhea.
5)Patients with active infection.
6)Patients with symptomatic brain metastasis.
7)Being treated with flucytosine, phenytoin,warfarin.
8)Uncontrolled psychiatric disease.
9) allergic more than and equal to grade3.
10)Patients with interstitial pneumonia or pulmonary fibrosis.
11)History of serious allergic reaction with S-1 or CBDCA.
12)Patients with pregnancy or lactation.
13)Patients with HIV,HBV
14)Any patients judged by the investigator to be unfit to participate in the study
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Kondo
Organization Institute of Health Biosciences , The University of Tokushima Graduate School
Division name Department of Oncological Medical Services
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Institute of Health Biosciences , The University of Tokushima Graduate School
Division name Department of Oncological Medical Services
Zip code
Address
TEL 088-633-9031
Homepage URL
Email

Sponsor
Institute Tokushima university hospital
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
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 04 Month 25 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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 07 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 04 Month 25 Day
Last modified on
2013 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012381

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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