UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of S-1 plus cisplatin with concurrent proton therapy for locally advanced NSCLC
Acronym	A phase II trial of S-1 plus cisplatin with concurrent proton therapy for locally advanced NSCLC
Scientific Title	A phase II trial of S-1 plus cisplatin with concurrent proton therapy for locally advanced NSCLC
Scientific Title:Acronym	A phase II trial of S-1 plus cisplatin with concurrent proton therapy for locally advanced NSCLC
Region	Japan

Condition
Condition	unresectable stage III NSCLC
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the efficacy and safety of concurrent chemoproton therapy for stage III locally advanced non-small cell lung cancer (NSCLC).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year overall survival
Key secondary outcomes	acute and late toxicity,response rate, local control rate, median survival, progression free survival,change of quality of life (QOL)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	concurrent chemo-proton 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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	(1) histologically or cytologically-confirmed unresectable stage III NSCLC (2) chemo-naive status (3) ECOG-PS, 0-1 (4) age, 20-74 years old (5) no previous radiotherapy around the lesion (6) no previous chemotherapy (7) dose constraints of the organs at risk achievable (8) lesions evaluable with RECIST (9) written informed consent
Key exclusion criteria	(1)superior vena caval syndrome (2)Other cancers within 5 years (3)active and uncontrolled infection (4)Other serious complications (5)IP or IPF on X-p (6)pregnancy or lactation (7)portal vein tumor thrombosis (8)severe psychological disorders (9)malignant pleural effusion (10)uses fluoropyrimidine antineoplastic agent or flucytosine (11) cases in which the doctor is judged inappropriate for medical, psychological or other reasons other than the above (12)a coronary stent and aortic stent graft
Target sample size	41

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Ogino
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Email	oginogio@gmail.com

Public contact
Name of contact person	1st name Hiromitsu Middle name Last name Iwata
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Homepage URL
Email	h-iwa-ncu@nifty.com

Sponsor
Institute	Nagoya City West Medical Center
Institute
Department

Funding Source
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
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	Clinical Study Committees of the Nagoya City Hospital
Address	1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel	052-721-7171
Email	rinsho1@higashi-hosp.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	2019 Year 06 Month 08 Day

Related information
URL releasing protocol	10.1016/j.ijrobp.2020.11.035
Publication of results	Published

Result
URL related to results and publications	10.1016/j.ijrobp.2020.11.035
Number of participants that the trial has enrolled	41
Results	The 2- and 5-year OS were 77% (95% confidence interval 64%-89%) and 59% (43%-76%) The median OS was not reached. No grade 3 or higher radiation pneumonitis was observed.
Results date posted	2021 Year 04 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	no less than 75 years old
Participant flow	All patients registered between August 2013 and August 2018
Adverse events	No grade 3 or higher radiation pneumonitis was observed.
Outcome measures	The 2- and 5-year OS were 77% (95% confidence interval 64%-89%) and 59% (43%-76%) The median OS was not reached. No grade 3 or higher radiation pneumonitis was observed.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 21 Day
Date of IRB	2013 Year 07 Month 03 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 05 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042125