UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036978 |
|---|---|
| Receipt number | R000042125 |
| Scientific Title | A phase II trial of S-1 plus cisplatin with concurrent proton therapy for locally advanced NSCLC |
| Date of disclosure of the study information | 2019/06/08 |
| Last modified on | 2021/04/12 22:16:36 |
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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
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
h-iwa-ncu@nifty.com
Sponsor or person
Institute
Nagoya City West Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042125
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