UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054375 |
|---|---|
| Receipt number | R000062105 |
| Scientific Title | Phase II study of stereotactic MR-guided online adaptive radiosurgery for small lung cancer |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/12/27 10:02:56 |
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Basic information
Public title
Phase II study of stereotactic MR-guided online adaptive radiosurgery for small lung cancer
Acronym
Stereotactic adaptive radiosurgery for small lung cancer
Scientific Title
Phase II study of stereotactic MR-guided online adaptive radiosurgery for small lung cancer
Scientific Title:Acronym
Stereotactic adaptive radiosurgery for small lung cancer
Region
| Japan |
Condition
Condition
primary lung cancer, metastatic lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of stereotactic MR-guided online adaptive radiosurgery for pathologically or clinically diagnosed primary lung cancer or solitary metastatic lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One-year local control and incidences of rib fracture
Key secondary outcomes
One-year overall survival time
One-year progression free survival
Incidences of serious adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To perform stereotactic MR-guided online adaptive radiosurgery for small lung cancer
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 or solitary metastatic lung cancer: lack of or controlled lymph node metastasis, pulmonary metastasis, and other distant metastases
2.Lung tumor was 5 cm or less in diameter and was not attached to chest wall
3.Tumor was not adjacent organ at risk: trachea, main~lobar bronchus, heart, spinal cord, brachial plexus, esophagus, stomach
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.Patients with severe complications such as uncontrolled diabetes, collagen disease, heart disease, lung disease, kidney disease, and mental illness
2.Receiving home oxygen therapy
3.Pregnant, lactating, or likelihood of pregnancy
4.Active infectious disease
5.History of radiation therapy that may overlap with the current treatment
6.Presence of obvious interstitial shadows on CT images
7.Cases with pacemakers, implanted defibrillators, or other internal metals incompatible with MRI
8.Claustrophobia preventing MRI examination
9.Patients with psychiatric illness or symptoms making participation in the study difficult to assess
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
takaya.yamamoto.c3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
Homepage URL
takaya.yamamoto.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
+81-22-728-4105
cirb@rinri.hosp.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062105
