UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009914 |
|---|---|
| Receipt number | 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 | 2020/12/01 14:18:09 |
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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
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
siniho@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011616
