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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011046
Receipt No. R000011904
Scientific Title Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia
Date of disclosure of the study information 2013/06/26
Last modified on 2014/07/01

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Basic information
Public title Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia
Acronym Phase II Trial of CBDCA + S-1 for NSCLC with IP
Scientific Title Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia
Scientific Title:Acronym Phase II Trial of CBDCA + S-1 for NSCLC with IP
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present study was planned with the objective of investigating the combination of carboplatin and S-1 in the treatment of previously untreated patients with advanced non-small-cell lung cancer complicated by interstitial pneumonia. This study is designed as a phase II study of assessment of the efficacy and safety.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Progression Free Survival, Overall Survival, 1 year survival rate, Quality of Life, 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 Six cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off)
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients
2)Incurable NSCLC with stage IIIB or stage IV
3)Patients with no prior chemotherapy or one year after adjuvant chemotherapy
4)Patients who have measurable lesion or evaluable lesion by RECIST
5)Age of 20 to 79 years old
6)ECOG PS 0-2
7)Patients with interstitial pneumonias
8)Patients with expected life for at 12 weeks
9)Patients who are able to take orally
10)Have adequate organ function within two week before study entry
WBC>=4000/mm3
Neutrophil>=1500/mm3
Hemoglobin>=9.0g/dl
Platelets>=100000/mm3
Total bilirubin>=1.5mg/dl
AST/ALT<=100IU
Creatinine<=1.2mg/dl
Creatinine clearance>=60mL/min
11) Merit with the chemotherapy
12) Written informed consent from the patients
Key exclusion criteria 1) Patients with pleural or pericardial effusion ,or ascites.
2) Patients with active double cancer.
3)Patients with significant complications.
4)Patients with serious diarrhea.
5)Patients with active infection.
6)Patients with symptomatic brain metastasis.
7)Being treated with flucytosine, phenytoin,warfarin.
8)Uncontrolled psychiatric disease.
9) allergic more than and equal to grade3.
10)History of serious allergic reaction with S-1 or CBDCA.
11)Patients with pregnancy or lactation.
12)Patients with HIV,HBV
13)Any patients judged by the investigator to be unfit to participate in the study
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiko Nishioka
Organization Tokushima University Hospital
Division name Department of Respiratory medicine and Rheumatology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima, Japan
TEL +81-88-633-7127
Email yasuhiko@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soji Kakiuchi
Organization Tokushima University Hospital
Division name Department of Respiratory medicine and Rheumatology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima, Japan
TEL +81-88-633-7127
Homepage URL
Email kakiuchi@clin.med.tokushima-u.ac.jp

Sponsor
Institute Department of Respiratory medicine and Rheumatology, Tokushima University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 徳島大学病院(徳島県)、徳島県立中央病院(徳島県)、徳島市民病院(徳島県)、徳島県立三好病院(徳島県)、高松赤十字病院(香川県)、国立病院機構高知病院(高知県)、高知医療センター(高知県)、高知赤十字病院(高知県)、松山赤十字病院(愛媛県)、国立病院機構大阪医療センター(大阪府)、聖路加国際病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 26 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 Preinitiation
Date of protocol fixation
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 26 Day
Last modified on
2014 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011904

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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