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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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26 April 2013 |
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Main ID: |
JPRN-C000000234 |
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Date of registration:
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24/11/2005 |
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Primary sponsor: |
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Public title:
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A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402
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Scientific title:
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Date of first enrolment:
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2005/02/01 |
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Target sample size:
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32 |
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Recruitment status: |
No longer recruiting |
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URL:
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http://www.umin.ac.jp/ctr/index.htm |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hideo Saka, M.D.
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Address:
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Japan |
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Telephone:
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Email:
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Affiliation:
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National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine |
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Name:
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Hideo Saka
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Address:
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4-1-1 Sannomaru, Naka-ku, Nagoya
Japan |
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Telephone:
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saka@nagoya.hosp.go.jp |
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Email:
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saka@nagoya.hosp.go.jp |
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Affiliation:
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National Hospital Organization, Nagoya Medical Center Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Advanced non-small cell lung cancer
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Intervention(s)
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Carboplatin and TS-1 chemotherapy
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Primary Outcome(s)
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Phase I: Safety, maximum tolerated doses, recommended doses
Phase II: Response rate
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Secondary Outcome(s)
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Phase I: Response rate
Phase II: Safety, survival time
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Source(s) of Monetary Support
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Central Japan Lung Study Group
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