UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002458
Receipt number R000002989
Scientific Title Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation
Date of disclosure of the study information 2009/09/08
Last modified on 2017/09/12 09:59:44

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Basic information

Public title

Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation

Acronym

Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation

Scientific Title

Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation

Scientific Title:Acronym

Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation

Region

Japan


Condition

Condition

primary lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the outcome of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

overall survival rate

Key secondary outcomes

progression-free survival rate, safety


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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) Patients with lung tumor less than 3cm in diameter and less than three lesions.
2) Patients unable to confirm pathological diagnosis.
3) Positive on FDG-PET except patients with GGO.
4) Apparent growth of lung tumor on CT.
5) Aged 20 years or more, 0-2 of ECOG performance status.
6) Patients must be consulted by surgeon.
7) Patients must be consulted by internal physician.
8) Able to make planning of radiotherapy within the regulation dose.
9) No history of radiation for chest.
10) PaO2 60 torr or more at room air, FEV1.0 700 ml or more.

Key exclusion criteria

1) Apparent interstitial pneumonia on chest X-ray.
2) Patinets with active infectious disease.
3) Patients with active other cancers.
4) Pregnant patients.
5) Patients with psychiatric disorders and unable to participate the study.
6) Patients now treated by steroids.
7) Patients who need oxygen inhalation.
8) Fever up.

Target sample size

65


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Shirato

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Radiology

Zip code


Address

North 15 West 7, Kita-ku, Sapporo, Japan

TEL

011-706-5977

Email

shirato@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Inoue

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Radiology

Zip code


Address

North 15 West 7, Kita-ku, Sapporo, Japan

TEL

011-706-5977

Homepage URL


Email

t-inoue@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Research group for low-risk and high-dose radiotherapy by highly advanced technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


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

北海道大学病院、他11施設


Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

With a median follow-up period of 55 months, the 3-year overall survival rate was 83% (95%CI:71-91%). Grade 3 and 4 chronic adverse event was experienced in 8 and 1 patients, respectively.

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

2009 Year 08 Month 21 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2017 Year 08 Month 14 Day

Date of closure to data entry

2017 Year 09 Month 07 Day

Date trial data considered complete

2017 Year 09 Month 07 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information

We observe patients treated by stereotactic body radiotherapy, who were clinically diagnosed as primary lung cancer without pathologic confirmation.


Management information

Registered date

2009 Year 09 Month 06 Day

Last modified on

2017 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002989


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name