UMIN-CTR Clinical Trial

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

lung tumor

Classification by specialty

Pneumology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Shinryoku neurosurgical clinic, Yokohama CyberKnife Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

02

Month

18

Day

URL releasing protocol

http://www.syck.jp/medical_care/cyberknife5.html

Publication of results

Published

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

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 related 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