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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002458
Receipt No. 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

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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
Institute Hokkaido University Hospital
Institute
Department

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
URL(English) https://upload.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


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