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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
