UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000006852