UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005061 |
|---|---|
| Receipt number | R000006004 |
| Scientific Title | A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors. |
| Date of disclosure of the study information | 2011/02/18 |
| Last modified on | 2018/08/17 19:14:47 |
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Basic information
Public title
A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.
Acronym
A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.
Scientific Title
A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.
Scientific Title:Acronym
A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SBRT with real-time tumor tracking using CyberKnife and Monte Carlo argorythm for lung tumors. (phase I study)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
incidence of Grade 3 or higher radiation pneumonitis within 180 days after stereotactic body radiotherapy
Key secondary outcomes
Overall survival, Progression-free survival, local progression-free survival, 3-year survival, 3 year local progression free survival, Event-free survival, 3 year local control rate, pattern of progression, Grade 2 or higher radiation pneumonitis, adverse event, severe adverse event
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
| Maneuver |
Interventions/Control_1
Stereotactic body radiotherapy using real-time tumor tracking with 45 or 50 or 55 Gy delivered in 4 fractions, once a day, twice a week.
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.Histologically or transbronchoscopic cytologically confirmed Primary or metastatic lung cancer diagnosed by images
2.cT1aN0M0,cT1bN0M0,cT2aN0M0(UICC7th) or lung oligometastasis within 5 cm diagnosed by images within 28 days
3.Dose constraints of the organs at risk seem to be limited within range
4.no previous radiotherapy around the lesion
5.20 years old or higher
6.ECOG-PS=0-2
7.Respiratory function (<=28 days)
(1)PaO2>=60 torr
(2)FEV1.0>=700 ml
8.Only tracking irradiation
9.Written informed consent
Key exclusion criteria
1.active infection needed therapy
2.fever of 38.0 degrees centigrade or higher
3.pregnancy
4.psychiatric disorder
5.steroid administration
6.Patients who are considered to be inappropriate for this study by physicians
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuta Shibamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Radiology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL
052-853-8276
yshiba@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Iwata |
Organization
Nagoya City West Medical Center
Division name
Nagoya Proton Therapy Center
Zip code
Address
1-1-1, Hirate-cho, Kita-ku, Nagoya
TEL
052-991-8588
Homepage URL
cyber@syck.jp
Sponsor or person
Institute
Department of Radiology, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinryoku neurosurgical clinic, Yokohama CyberKnife 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
新緑脳神経外科横浜サイバーナイフセンター(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
http://www.syck.jp/medical_care/cyberknife5.html
Publication of results
Published
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
| 2011 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
| 2011 | Year | 02 | Month | 10 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006004
