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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009914
Receipt No. R000011616
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
Date of disclosure of the study information 2013/01/31
Last modified on 2017/08/07

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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 No longer recruiting
Date of protocol fixation
2012 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 04 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
2013 Year 01 Month 31 Day
Last modified on
2017 Year 08 Month 07 Day


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

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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