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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000054
Receipt No. R000000100
Scientific Title Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
Date of disclosure of the study information 2005/09/04
Last modified on 2005/09/08

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Basic information
Public title Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
Acronym Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
Scientific Title Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
Scientific Title:Acronym Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
Region
Japan

Condition
Condition non small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the maximum tolerable dose and recommended dose of TS1 and carboplatin., and to determine the efficacy and safety of the combination of TS1 and carboplatin in patients with NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decision of the recommended dose of TS1 and carboplatin
Key secondary outcomes Determination of dose limited toxicity and response and safety of the combination of TS1 and carboplatin

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 TS1: 65 or 80 mg/body/day, orally 14 days, every 3 weeks
Carboplatin: AUC 4.0, 5.0 or 6.0
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) Stage IIIB or IV NSCLC
2) No indication of curable chemoradiation
3) Chemonaive
4) At least one measurable lesion
5) 75 > Age > 20 years
6) Performance status (PS) of 0 to 1
7) Adequate main organ functions
WBC > 4000/mm3
Plt > 100000/mm3
Hb > 9.0g/dl
T-bil < 2.0mg/dl
GOT < 100 IU/L, GPT < 100IU/L
Creatinine clearance < normal range
PaO2 > 60mmHg
8) No limitation of outpatients
9) Written informed consent
Key exclusion criteria 1) History of active other malignancy
2) Severe heart disease (uncontrolled angina pectoris , myocardial infarction, heart failure within 3 months
3) Uncontrolled diabetes
4) Severe complication (infection, bowel obstruction, or hemorrhage etc.)
5) Intestinal pneumonia or lung fibrosis
6) Severe diarrhea
7) Massive pleural, cardiac, or abdominal effusion
8) Regular use of fenitoin, warfarin or frucitocin
9) Symptomatic brain metastasis
10) History of severe drug allergic reaction
11) History of bone marrow plantation or self peripheral blood stimulated transportation
12) Pregnant women or women willing child-bearing
13) Inadequate condition diagnosed by primary physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura MD
Organization Kinki University School of Medicine, Nara Hospital
Division name Department of Medical Oncology
Zip code
Address 1248-1, Otoda, Ikoma, Nara, 630-0293, Japan
TEL 0743-77-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine, Nara Hospital
Division name Department of Medical Oncology
Zip code
Address
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute Department of Medical Oncology,

Kinki University School of Medicine

Institute
Department

Funding Source
Organization Department of Medical Oncology,

Kinki University School of Medicine

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
2005 Year 09 Month 04 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
Date of protocol fixation
2005 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2005 Year 02 Month 01 Day
Last follow-up date
2007 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 08 Month 10 Day
Last modified on
2005 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000100

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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