UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016575 |
|---|---|
| Receipt number | R000018984 |
| Scientific Title | Real-time tumor-tracking proton beam therapy for lung cancer |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2017/08/21 10:41:35 |
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Basic information
Public title
Real-time tumor-tracking proton beam therapy for lung cancer
Acronym
Real-time tumor-tracking proton beam therapy for lung cancer
Scientific Title
Real-time tumor-tracking proton beam therapy for lung cancer
Scientific Title:Acronym
Real-time tumor-tracking proton beam therapy for lung cancer
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of real-time tumor-tracking proton beam therapy for non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of radiation pneumonitis at six months after real-time tumor-tracking proton beam therapy
Key secondary outcomes
3-year overall survival, local control, progression free survival, recurrence pattern, incidence of adverse effect, incidence of dropout and migration of Au markers during treatment period
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Real-time tumor-tracking proton beam 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically proven non-small cell lung cancer
2) T1-3N0M0(UICC 7th edition)
3) Inoperative or operation refused
4) Visible target on CT
5) ECOG-PS 0-2
6) Age 20-yrs old or over at the time of consent form is obtained
7) Explained well and consent to this study
Key exclusion criteria
1) With active infections in the irradiated sites
2) With active other cancers
3) With severe uncontrolled diabetes
4) With severe renal failure which needed dialysis
5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia
6) Previous thoracic irradiation
7) Previous chemotherapy within 12 months before enrollment
8) FEV 1.0 under 700 ml
9) With implantable cardioverter defibrillator or permanent pacemaker
10) Pregnancy
11) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
12) Cannot be held rest for about 30 minutes
13) Weight over 135 kg
14) Cannot be implanted Au marker in the lung
15) Allergic to radiation
16) Unsuitable for enrollment judged by principal investigator
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Shirato |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-5977
shirato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Inoue |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-5977
Homepage URL
t-inoue@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
北海道大学病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | 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
| 2015 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018984
