UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010593 |
|---|---|
| Receipt number | 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 14:28:56 |
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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
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
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012381
