UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000234 |
|---|---|
| Receipt number | R000000295 |
| Scientific Title | A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402 |
| Date of disclosure of the study information | 2005/11/24 |
| Last modified on | 2013/09/21 03:01:59 |
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Basic information
Public title
A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402
Acronym
A phase I/II Study of CBDCA+TS-1 in Non-small Cell Lung Cancer
Scientific Title
A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402
Scientific Title:Acronym
A phase I/II Study of CBDCA+TS-1 in Non-small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In phase I portion, the optimal dosases of carboplatin and TS-1 will be determined. In phase II, the response rate will be measured in advanced non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I: Safety, maximum tolerated doses, recommended doses
Phase II: Response rate
Key secondary outcomes
Phase I: Response rate
Phase II: Safety, survival time
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
Carboplatin and TS-1 chemotherapy
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. Histologycally or cytologically proven non-small cell lung cancer
2. Stage IIIB with no indication of radiation therapy, and Stage IV
3. Measurable by RECIST critelia in phase II portion.
4. Age over 19 years-old, and less than 75 years-old.
5. ECOG Performance Status of 0 or 1
6. Chemo-naive
7. Post-operative or asymptomatic brain metastasis or radiation therapy to the non-target lesion is allowed.
8. Adequate bone marrow, liver, and renal functions
WBC > 4,000 /uL
Neutro > 2,000 /uL
Platlets > 100,000 /uL
Hb > 9.5 g/dL
s-Cr < 1.5 mg/dL
Ccr > 30 mL/min
AST, ALT < 100 IU/L
T.Bil < 1.5 mg/dL
PzO2 > 60 mmHg or SpO2 > 90%
9. Written informed consent
Key exclusion criteria
1. Massive pleural effusion with the incication of local therapy
2. Clinically appearent pericardial effusion
3. Serious medical complications:
Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure.
Uncontrolled diabetes mellitus, hypertension, infections.
Contraindication for carboplatin or TS-1 use
4. Pulmonary fiblosis detectable on chest X-ray films
5. Pregnant or milk-feeding female. Intention to be pregnant in the future
6. Other clinical difficulites to this study
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Saka, M.D. |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Japan
TEL
+81-52-951-1111
saka@nagoya.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Saka, M.D. |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya
TEL
+81-52-951-111
Homepage URL
saka@nagoya.hosp.go.jp
Sponsor or person
Institute
Central Japan Lung Study Group
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 11 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000295
