UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014815
Receipt number R000017225
Scientific Title A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor
Date of disclosure of the study information 2014/09/01
Last modified on 2018/02/11 09:50:50

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Basic information

Public title

A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor

Acronym

Dose escalation study in stereotactic body radiotherapy for the lung tumor

Scientific Title

A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor

Scientific Title:Acronym

Dose escalation study in stereotactic body radiotherapy for the lung tumor

Region

Japan


Condition

Condition

Lung Cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and the efficacy of the dose escalation in stereotactic body radiotherapy for the lung tumor

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of adverse effect

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Dose escalation in radiotherapy

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) Primary or metastatic lung cancer
A. Primary lung cancer;
Tumor size </=5cm, and clinical stage IA or IB
B. Metastatic lung cancer;
Tumor size </=5cm, two lung lesions or less, and no lesions other than lung
2) Those who are inoperable or who refuse surgery
3) Dose to adjacent organ is not estimated to exceed constraints in pretreatment chest CT
4) Patients' age must be>/=20 years old
5) ECOG performance status must be 0-2
6) Patients can lay on their back holding their arms over the heads, and keep that position at least 30 minutes

Key exclusion criteria

1) previous irradiation around the lesion
2) With active interstitial pneumonia or pulmonary fibrosis
3) With severe diabetic mellitus or collagen disease
4) Women during pregnancy or lactating , or who might be pregnant
5) With psychiatric illness which impede protocol treatment
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 Yukinori Matsuo

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code


Address

54 Shogoin Kawaharacho Sakyo-ku, Kyoto

TEL

075-751-3762

Email

ymastuo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takamasa Mitsuyoshi

Organization

Kyoto University Hospital

Division name

Department of Radiation Therapy

Zip code


Address

54 Shogoin Kawaharacho Sakyo-ku, Kyoto

TEL

075-751-3762

Homepage URL


Email

mitsu.t@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 01 Day


Related information

URL releasing protocol


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

Completed

Date of protocol fixation

2014 Year 08 Month 05 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date

2017 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 10 Day

Last modified on

2018 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017225


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name