UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023075 |
|---|---|
| Receipt number | R000026596 |
| Scientific Title | A phase II clinical trial of carbon-ion radiotherapy for patients with peripherally located stage I non-small-cell lung cancer |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2016/07/08 13:02:29 |
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Basic information
Public title
A phase II clinical trial of carbon-ion radiotherapy for patients with peripherally located stage I non-small-cell lung cancer
Acronym
phase II trial of carbon-ion radiotherapy for preipherally located stage I non-small-cell lung cancer
Scientific Title
A phase II clinical trial of carbon-ion radiotherapy for patients with peripherally located stage I non-small-cell lung cancer
Scientific Title:Acronym
phase II trial of carbon-ion radiotherapy for preipherally located stage I non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Peripheraly located 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 peropherally located stage I non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
3-year local control rate
Key secondary outcomes
3- and 5-year overall survival rate
3- and 5-year cause-specific survival rate
3- and 5-year progression-free survival rate
Toxicities
Pulmonary function (VC, FEV1.0) at 3 years
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Carbon-ion radiotherapy
T1:54.0GyRBE/4fractions
T2:64.0GyRBE/4fractions
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pathologically confirmed NSCLC
2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET
3)No history of thoracic irradiation
4)Medically inoperable or refuse surgery
5)Exist of lesion for evaluation
6)No history of chemotherapy within 2 weeks
7)20 year-old or > 20 year-old
8)Estimated survival longer than 6 months
9)Informed consent by document
Key exclusion criteria
1)Interstitial pneumonitis on CT images
2)< SpO2 94%
3)Severe infections in treatment area
4)Coexisting malignancies within 2 years excepting Carcinoma in Situ, stgae I laryngeal cancer, localized prostate cancer
5)Pregnancy
6)Unfit due to mental disorders
7)Continuouslly oral or intravenous administration of steroid
8)Other reasons judged by physician
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Division name
Department of Radiation Oncology
Zip code
Address
3049 Harakoga-machi, Tosu, Japan
TEL
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Division name
Department of Radiation Oncology
Zip code
Address
3049 Harakoga-machi, Tosu, Japan
TEL
0942-81-1897
Homepage URL
shioyama-yoshiyuki@saga-himat.jp
Sponsor or person
Institute
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Institute
Department
Personal name
Funding Source
Organization
None
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
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
九州国際重粒子線がん治療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | 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
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2016 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026596
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