UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022855
Receipt number R000025729
Scientific Title Phase II study of stereotactic radiosurgery with volumetric modulated arc therapy for small lung cancer
Date of disclosure of the study information 2016/07/27
Last modified on 2022/12/28 11:07:04

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Basic information

Public title

Phase II study of stereotactic radiosurgery with volumetric modulated arc therapy for small lung cancer

Acronym

Stereotactic radiosurgery for small lung cancer

Scientific Title

Phase II study of stereotactic radiosurgery with volumetric modulated arc therapy for small lung cancer

Scientific Title:Acronym

Stereotactic radiosurgery for small lung cancer

Region

Japan


Condition

Condition

primary lung cancer, metastatic lung cancer

Classification by specialty

Pneumology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of stereotactic radiosurgery with volumetric modulated arc therapy for small lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3-year in-field tumor control rate

Key secondary outcomes

3-year overall survival time
3-year marginal failure rate
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

Other

Interventions/Control_1

Perform stereotactic radiosurgery with volumetric modulated arc therapy for small lung cancer

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 or clinically diagnosed primary lung cancer or solitary metastatic lung cancer.
2.tumor diameter:5 cm >=
3.tumor located 1cm away from chaest wall
4.tumor located 2cm away from organ at risk
5.forced expiratory volume 1.0:700 mL <=
6.Performance status(ECOG):0-2
7.medically inoperable or patient who refused surgery
8.written informed consent

Key exclusion criteria

1. no serious diabetes, collagen disease, cardiac disease, pulmonary disease, kidney disease and psychological disorder
2.Single lung
3.receiving home oxygen therapy
4. pregnant or lactating woman, likelihood of pregnancy
5. active infectious disease
6. implanted pacemaker or implantable cardioverter defibrillator
7. no history of thoracic radiation therapy

Target sample size

21


Research contact person

Name of lead principal investigator

1st name Takaya
Middle name
Last name Yamamoto

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Radiuation Oncology

Zip code

980-8574

Address

Seiryo-machi 1-1, Aoba-ku, Sendai

TEL

+81-22-717-7312

Email

t.yamamoto@rad.med.tohoku.ac.jp


Public contact

Name of contact person

1st name See above
Middle name
Last name See above

Organization

See above

Division name

See above

Zip code

980-8574

Address

See above

TEL

+81-22-717-7312

Homepage URL


Email

t.yamamoto@rad.med.tohoku.ac.jp


Sponsor or person

Institute

Department of Radiuation Oncology, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of tohoku university

Address

1-1, seiryo-machi, aoba-ku, sendai city, Japan

Tel

022-728-4105

Email

rinri-2@proj.med.tohoku.ac.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/36010985/

Number of participants that the trial has enrolled

21

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

Completed

Date of protocol fixation

2016 Year 05 Month 08 Day

Date of IRB

2016 Year 07 Month 15 Day

Anticipated trial start date

2016 Year 07 Month 27 Day

Last follow-up date

2022 Year 07 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 23 Day

Last modified on

2022 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name