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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007433
Receipt No. R000008747
Scientific Title A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma
Date of disclosure of the study information 2012/03/02
Last modified on 2012/09/14

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Basic information
Public title A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma
Acronym CJLSG1102
Scientific Title A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma
Scientific Title:Acronym CJLSG1102
Region
Japan

Condition
Condition Squamous Cell Lung Carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to assess the effectiveness and safety of maintenance therapy for patients previously untreated non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 12w-Disease control rate
Key secondary outcomes Overall Survival,
Progression Free Survival,
Ratio of entering to Maintenance Therapy,
Safety,
Quality of Life

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 S-1 followed by S-1 maintenance
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Better than SD after 4 cycles of S-1 plus carboplatin as initial therapy.
2) ECOG performance status (PS): 0-2
3) Adequate organ function.
Key exclusion criteria 1) Active infection or other serious disease condition (poorly controlled diabetes mellitus, cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.).
2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease,pneumoconiosis,active radiation pneumonia,etc.).
3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome.
4) Symptomatic brain metastasis.
5) Grade 2 or higher diarrhea
6) Pregnant or nursing females
7) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryujiro Suzuki
Organization Toyohashi Municipal Hospital
Division name Department of Respiratory Medicine
Zip code
Address 50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.
TEL 0532-33-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Takeyama
Organization Toyohashi Municipal Hospital
Division name Department of Respiratory Medicine
Zip code
Address 50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.
TEL 0532-33-6111
Homepage URL
Email

Sponsor
Institute Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization Central Japan Lung Study Group (CJLSG)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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 Central Japan Lung Study Group (CJLSG)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 02 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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
2016 Year 02 Month 01 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2016 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 02 Day
Last modified on
2012 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008747

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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