UMIN-CTR Clinical Trial

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
Email	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
Email	saka@nagoya.hosp.go.jp

Sponsor
Institute	Central Japan Lung Study Group
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000295

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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