UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.
Title of the study (Brief title)	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	Yuta Shibamoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Radiology
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	Hiromitsu Iwata
Organization	Nagoya City West Medical Center
Division name	Nagoya Proton Therapy Center
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 02 Month 04 Day
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

Related information
URL releasing protocol	http://www.syck.jp/medical_care/cyberknife5.html
Publication of results	Published
URL releasing results
Results
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