UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022856 |
|---|---|
| Receipt number | R000025821 |
| Scientific Title | Phase II study of stereotactic radiotherapy with volumetric modulated arc therapy for primary lung cancer located adjacent to organ at risk |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2022/12/28 11:06:41 |
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Basic information
Public title
Phase II study of stereotactic radiotherapy with volumetric modulated arc therapy for primary lung cancer located adjacent to organ at risk
Acronym
Stereotactic radiotherapy for primary lung cancer located adjacent to organ at risk
Scientific Title
Phase II study of stereotactic radiotherapy with volumetric modulated arc therapy for primary lung cancer located adjacent to organ at risk
Scientific Title:Acronym
Stereotactic radiotherapy for primary lung cancer located adjacent to organ at risk
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of stereotactic radiotherapy with volumetric modulated arc therapy for primary lung cancer located adjacent to organ at risk
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year in-field tumor control rate
Key secondary outcomes
1-year overall survival rate,
1-year in-field tumor control rate,
the rate of 1-year adverse reaction,
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
| Other |
Interventions/Control_1
Perform stereotactic radiotherapy with volumetric modulated arc therapy for primary lung cancer located adjacent to organ at risk
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.Pathologically or clinically diagnosed primary lung cancer.
2.tumor diameter:5 cm >=
3.tumor centrally located or located within 2cm of organ at risk
4.forced expiratory volume 1.0:700 mL <=
5.Performance status(ECOG):0-2
6.medically inoperable or patient who refused surgery
7.written informed consent
Key exclusion criteria
1. no serious diabetes, collagen disease, cardiac disease, pulmonary disease, kidney disease and psychological disorder
2. past history or future plan of administration of molecular target drug affecting VEGF or FGF pathways
3. apparent interstitial pneumonitis or pulmonary fibrosis on CT images
4.receiving home oxygen therapy
5. Single lung
6.pregnant or lactating woman, likelihood of pregnancy
7. active infectious disease
8.implanted pacemaker or implantable cardioverter defibrillator
9. no history of thoracic radiation therapy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiuation Oncology
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
t.yamamoto@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | See above |
| Middle name | |
| Last name | See above |
Organization
See above
Division name
See above
Zip code
980-8574
Address
See above
TEL
+81-22-717-7312
Homepage URL
t.yamamoto@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Radiuation Oncology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Institutional Review Board of tohoku university
Address
1-1, seiryo-machi, aoba-ku, sendai city, Japan
Tel
022-728-4105
rinri-2@proj.med.tohoku.ac.jp
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
東北大学大学院医学系研究科放射線腫瘍学分野/Department of Radiuation Oncology, Tohoku University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 27 | 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
15
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
| 2016 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025821
