UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005061
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email cyber@syck.jp

Sponsor
Institute Department of Radiology, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.