UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000054 |
|---|---|
| Receipt number | 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 11:07:22 |
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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
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
Sponsor or person
Institute
Department of Medical Oncology,
Kinki University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000100
