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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001721
Receipt No. 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

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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
Institute Aichi Cancer Center Hospital
Institute
Department

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
URL(English) https://upload.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


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