UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001721
Receipt number R000002057
Scientific Title Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.
Date of disclosure of the study information 2009/02/20
Last modified on 2018/02/26 19:11:39

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Basic information

Public title

Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.

Acronym

SBRT with helical tomotherapy for lung cancer

Scientific Title

Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.

Scientific Title:Acronym

SBRT with helical tomotherapy for lung cancer

Region

Japan


Condition

Condition

stage IA non-small cell lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess clinical feasibility of stereotactic body radiation therapy with helical tomotherapy for stage IA lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

3-year overall survival rate

Key secondary outcomes

overall survival time, relapse-free survival time, local pregression-free survival time, 3-year local progression free rate, type of recurrence, acute adverse event, late adverse event, ratio of 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

Device,equipment

Interventions/Control_1

patient number 50, accrual 4 years, follow-up 3years
stereotactic body radiation therapy 60Gy/6fraction/8-12 days

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

histologically confirmed
stage IA
no mediastinal lymph node metastasis
no previously radiotherapy history
Performance status 0-2
medically unresectable or refuse of surgery
written, informed consent

Key exclusion criteria

interstitial pneumonitis, lung fibrosis
active infection
active multiple cancer (last 3 years)
pregnancy or breast feeding
psychological disorder
systemic steroid medication

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Kodaira

Organization

Aichi Cancer Center Hospital

Division name

Department of Therapeutic Radiation Oncology

Zip code


Address

1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi

TEL

052-762-6111

Email

109103@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Natsuo Tomita

Organization

Aichi Cancer Center Hospital

Division name

Department of Therapeutic Radiation Oncology

Zip code


Address

1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi

TEL

052-762-6111

Homepage URL


Email

ntomita@aichi-cc.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Aichi Cancer Center Hospital

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2009 Year 02 Month 20 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


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

Terminated

Date of protocol fixation

2009 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2009 Year 02 Month 20 Day

Last follow-up date

2016 Year 02 Month 01 Day

Date of closure to data entry

2016 Year 02 Month 01 Day

Date trial data considered complete

2016 Year 02 Month 01 Day

Date analysis concluded

2016 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 02 Month 20 Day

Last modified on

2018 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name