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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005794
Receipt No. R000006852
Scientific Title Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Date of disclosure of the study information 2011/06/20
Last modified on 2019/06/22

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Basic information
Public title Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Acronym Phase I/II trial of CBDCA+TS-1+RT in elderly patients with locally advanced NSCLC
Scientific Title Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Scientific Title:Acronym Phase I/II trial of CBDCA+TS-1+RT in elderly patients with locally advanced NSCLC
Region
Japan

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

Objectives
Narrative objectives1 To determine recommended dose, efficacy, and safety of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression-free survival rate at one year
Key secondary outcomes

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, TS-1, and concurrent thoracic radiation therapy
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
71 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically diagnosed as non-small cell lung cancer
2) Unresectable locally advanced
3) Clinical stage III (UICC 7th edition)
4) Indication of radical thoracic radiation therapy
5) No prior chemotherapy or radiation therapy
6) Performance status 0-1
7) Age of 71 years or older
8) Adequate organ function
9) Life expectancy of at least 3 months
10) Written informed consent
Key exclusion criteria 1) Active concomitant malignancy
2) Infection, ileus, vomiting
3) Uncontrolled ulcer, diabetes mellitus
4) Interstitial pneumonia
5) Drug allergy
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Ohe
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email yohe@east.ncc.go.jp

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Niho
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email siniho@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Fund for cancer research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Review Board
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.jp

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
2011 Year 06 Month 20 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 40
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 Main results already published
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
2011 Year 06 Month 09 Day
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2018 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 16 Day
Last modified on
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006852

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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