UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023398 |
|---|---|
| Receipt number | R000023120 |
| Scientific Title | Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2024/08/09 15:33:23 |
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Basic information
Public title
Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer
Acronym
Multi-institutional Clinical Trial of C-ion RT for Peripherally Stage-I NSCLC
Scientific Title
Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer
Scientific Title:Acronym
Multi-institutional Clinical Trial of C-ion RT for Peripherally Stage-I NSCLC
Region
| Japan |
Condition
Condition
Peripherally located inoperable stage-I non-small-cell lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of Carbon-ion radiotherapy for peripherally located inoperable stage I non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
3-year overall survival rate
Key secondary outcomes
Toxicities
Median survival time
2-year overall survival rate
2- and 3-year cause-specific survival rate
2- and 3-year progression-free survival rate
2- and 3-year local-progression-free rate
2- and 3-year local-progression-free survival rate
Pattern of recurrences
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
| Device,equipment | Maneuver |
Interventions/Control_1
Carbon-ion radiotherapy
60.0GyRBE/4fractions (15.0GyRBE/fraction)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Pathologically confirmed or clinically diagnosed NSCLC
2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET, and peripherally located
3)Considered to be unfit to lobar resection by cancer board including thoracic surgeon, pulmonary medical oncologist and radiation oncologist
4)Exist of lesion for evaluation
5)Initial treatment for the lesion
6)PS(ECOG) 0-2
7)SpO2 >= 90% or PaO2 >= 60 torr(mmHg)
8)FEV1.0 >= 700ml
9)>= 20 years-old / =< 90 years-old
10)Written informed consent
Key exclusion criteria
1)Severe comorbidities including infection and mental disorders
2) Interstitial pneumonitis on CT images
3)Coexisting malignancies within 2 years excepting Carcinoma in situ, stage-I laryngeal cancer, stage-I prostate cancer and stage-I breast cancer
4)History of thoracic irradiation
5)Pregnancy
6)Enrolled in other clinical trials with Interventions
7)Other reasons judged by physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | hiroaki |
| Middle name | |
| Last name | suefuji |
Organization
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Division name
Department of Radiation Oncology
Zip code
841-0071
Address
3049 Harakoga-machi, Tosu, Japan
TEL
0942-81-1897
sufg@saga-himat.jp
Public contact
Name of contact person
| 1st name | hiroaki |
| Middle name | |
| Last name | suefuji |
Organization
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Division name
Department of Radiation Oncology
Zip code
841-0071
Address
3049 Harakoga-machi, Tosu, Japan
TEL
0942-81-1897
Homepage URL
1501lung@saga-himat.jp
Sponsor or person
Institute
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ion Beam Therapy Center, SAGA-HIMAT Foundation Institutional Review Board
Address
3049 Harakoga-machi, Tosu, Japan
Tel
0942-81-1897
saga-himat@saga-himat.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
J-CROS 1501 LUNG
Org. issuing International ID_1
Japan Carbon-ion Radiation Oncology Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州国際重粒子線がん治療センター(佐賀県）、QST病院（千葉県）、群馬大学重粒子医学研究センター（群馬県）、兵庫県立粒子線医療センター（兵庫県）、神奈川県立がんセンター（神奈川県）、大阪重粒子線センター（大阪府）、山形大学医学部附属病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
56
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
| 2016 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023120
