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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008083
Receipt No. R000009518
Scientific Title A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Date of disclosure of the study information 2012/06/01
Last modified on 2018/12/17

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Basic information
Public title A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Acronym A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Scientific Title A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Scientific Title:Acronym A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Region
Japan

Condition
Condition Chemo-Naïve Patients with Squamous Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Carboplatin plus oral S1 followed by maintenance S1 treatment in Chemo-Naive Patients stage IIIB/IV with Squamous Cell Lung Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival, Progression-free survival of maintenance treatment, Overall survival, Frequency and grade of adverse event

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 AUC = 5(day1)+ S-1 80mg/m2 (day1~14) q3weeks 6 cycles followed by +S-1 80mg/m2(day1~14) q3weeks until disease progression
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.Histologically or cytologically confirmed squamous cell lung cancer
2.Stage IIIB/IV without any indications for radiotherapy, or recurrent disease after surgery
3.Measurable disease
4.Except for the surgical treatment for non-small cell lung cancer, patients have not been conducted prior treatment (radiation therapy, and chemotherapy)However, radiation therapy is not applied radiation field in the primary tumor, two weeks after irradiation final at the time of registration it is acceptable)
5.Age 20=<
6.ECOG performance status of 0 to 1
7.Patiants who can take in drug orally
8.Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 3,500 /mm3
Neu >= 1,500 /mm3
Plt >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
AST (GOT) , ALT (GPT) =< 100 IU/L
T. bil =< 1.5 mg/dL
Cr >= 1.2mg/dL
SpO2 >= 90% or >= 60 torr
9.Expected to live over 12 weeks after administration days
10.Written informed consent from the patients
Key exclusion criteria 1.Adjuvant chemotherapy
2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia.
3.History of severe drug allergy
4.Active synchronous malignancies
5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
6.Severe complication
7.Metastasis to CNS
8.Patients with chest radiation treatment is required to reach the lung irradiation
9.Treated by flucytosine (5-FC)
10.Women with a possibility of pregnancy, pregnant or lactating
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 2-15 Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3833
Email tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 2-15 Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3833
Homepage URL
Email tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute Dept. of Respiratory Medicine,
Osaka University Hospital
Institute
Department

Funding Source
Organization Dept. of Respiratory Medicine,
Osaka University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor OSAKA-LCSG
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
2012 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In the 33 patients analyzed, the rate of patients who met the primary endpoint was 30.3% (95% confidence interval: (15.6%-48.7%), and the disease control rate was 75.8%. The median PFS and OS were 3.5 and 11.3 months, respectively. Ten patients received maintenance S-1, and the median PFS from the beginning of induction treatment was 5.3 months. Grade 3/4 toxicities with a frequency of more than 5% were all controllable.
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 Completed
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 01 Month 31 Day
Date of closure to data entry
2016 Year 01 Month 31 Day
Date trial data considered complete
2016 Year 01 Month 31 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 01 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009518

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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