UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer
Acronym	Randomized phase II study of CDDP+S-1+TRT vs. CDDP+PEM+TRT for locally advanced non-sq NSCLC.
Scientific Title	A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer
Scientific Title:Acronym	Randomized phase II study of CDDP+S-1+TRT vs. CDDP+PEM+TRT for locally advanced non-sq NSCLC.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of CDDP+S-1P+TRT and CDDP+PEM+TRT in patients with locally advanced non-squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	2-year progression-free survival rate
Key secondary outcomes	Rate of treatment completion, rate of adverse events, response rate, overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination chemotherapy of S-1 plus cisplatin and concurrent thoracic radiotherapy
Interventions/Control_2	Combination chemotherapy of pemetrexed plus cisplatin and concurrent thoracic radiotherapy
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Pathologically proven non-squamous non-small cell lung cancer (2) Clinical stage IIIA or IIIB based on the UICC TNM classification 7th edition (3) Unresectable (4) Having indication of defenitive thoracic radiotherapy (5) No prior chemotherapy or radiotherapy (6) ECOG PS of 0 or 1 (7) PaO2 >= 70 Torr or SpO2 >= 93% (8) Adequate organ function (9) Expected the rest of life over 12 weeks (10) Age of 20 to 70 years (11) Written informed consent by patients
Key exclusion criteria	(1) active concomitant malignancy (2) Infection, ileus, or gastrointestinal obstruction (3) Uncontrolled peptic ulcer or diabetes (4) Intestinal pneumonia or severe emphysema (5) Severe drug allergy (6) Concomitant use of other investigational drugs, warfarin, or flucytosine (7) Positive of HBsAg (8) Pregnancy or breast-feeding
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuichiro Ohe
Organization	National Cancer Center Hospital
Division name	Department of Thoracic Oncology
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	yohe@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Seiji Niho
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Zip code
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	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Cancer Institute Hospital, Japanese Foundation for Cancer Research; Shizuoka Cancer Center
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	癌研究会有明病院、静岡県立静岡がんセンター、九州がんセンター、愛知県がんセンター中央病院、国立がん研究センター中央病院、関西医科大学附属枚方病院、横浜市立市民病院、兵庫県立がんセンター

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 31 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	Main results already published
Date of protocol fixation	2012 Year 12 Month 05 Day
Date of IRB	2012 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 04 Day
Last follow-up date	2019 Year 01 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 02 Month 19 Day

Other
Other related information

Management information
Registered date	2013 Year 01 Month 31 Day
Last modified on	2020 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011616