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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009308
Receipt No. R000010930
Scientific Title Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Date of disclosure of the study information 2013/01/01
Last modified on 2017/11/14

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Basic information
Public title Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Acronym Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Scientific Title Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Scientific Title:Acronym Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Region
Japan

Condition
Condition Squamous cell carcinoma of the lung
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and feasibilty for Carboplatin and alternate-day administrations of TS-1 in patients with squamous 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 Disease control rate (CR+PR+SD)
Key secondary outcomes 1.Overall survival
2.Progression-free survival from induction chemotherapy
3.Progression-free survival from maintenance chemotherapy
4.Percrntages of patients who received maintenance chemotherapy
5.Response rate
6.Toxicities

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 Induction chemotherapy with Carboplatin and alternate-day administrations of TS-1
for all registered patients.

Maintenance chemotherapy with alternate-day administrations of TS-1 for non-PD patients.
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 carcinoma of the lung
2.Stage IIIB/IV
3.Age >=20
4.PS(Eastern Cooperative Oncology Group:ECOG):0-2
5.Measurable lesion
6.Capable of oral intake
7.Adequate organ functions
neutrophils >=1,500/mm3
platelets >=100,000/mm3
hemoglobin >=9.0g/dL
total bilirubin <=2.0mg/dL
AST(GOT)/ALT(GPT) <=100IU/L
PaO2 >= 60torr or SpO2 >=90%
creatinine clearance >=30mL/min
8.Estimated life expectancy of at least 3 months
9.With written informed consent
Key exclusion criteria 1.Contraindication of TS-1, CBDCA
2)Patients received adjuvant chemotherapy
3.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
4.Active infection
5.HBs antigen positive
6.Severe complications, such as ileus, heart failure and renal failure
7.Continuous diarrhea
8.Massive pleural effusion and ascites
9.Active concomitant malignancy
10.Patients under treatment with flucytosine, phenytoin or warfarin potassium
11.Patients under treatment with steroids
12.Inadequate physical condition, as diagnosed by primary physician
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Young Hak Kim
Organization Kyoto University Hospital
Division name Respiratory Medicine
Zip code
Address 54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
TEL 075-751-3830
Email ekim@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Nagai
Organization Kyoto University Hospital
Division name Respiratory Medicine
Zip code
Address 54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
TEL 075-751-3830
Homepage URL
Email hwithe@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 京都大学附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 01 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 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 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
2012 Year 11 Month 10 Day
Last modified on
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010930

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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