UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048728 |
|---|---|
| Receipt number | R000055515 |
| Scientific Title | Daily irradiation versus irradiation at two- to three-day intervals in stereotactic radiotherapy for patients with 1-5 brain metastases: a multicenter randomized phase II trial |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/10/18 13:08:02 |
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Basic information
Public title
Daily irradiation versus irradiation at two- to three-day intervals in stereotactic radiotherapy for patients with 1-5 brain metastases: a multicenter randomized phase II trial
Acronym
Consecutive vs intervals-BM SRT
Scientific Title
Daily irradiation versus irradiation at two- to three-day intervals in stereotactic radiotherapy for patients with 1-5 brain metastases: a multicenter randomized phase II trial
Scientific Title:Acronym
Consecutive vs intervals-BM SRT
Region
| Japan |
Condition
Condition
Brain metastasis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the optimal interval of stereotactic radiotherapy (SRT) in three fractions and elucidate the efficacy and safety of daily irradiation (standard arm) with irradiation at two- to three-day intervals (experimental arm) for patients with one to five brain metastases with less than 3.0 cm diameter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Intracranial local control rate (IC-LC), defined as intracranial local control at initially treated sites.
Key secondary outcomes
1. Intracranial progression-free survival (IC-PFS), defined as intracranial PFS at initially treated and new sites.
2. Overall survival (OS), defined as the time from the date of randomization to death from any cause.
3. Toxicity, assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
4. Non-worsening of Karnofsky performance status (KPS), defined as the time from randomization to decline of KPS from any cause.
5. Non-worsening of mini mental status examination (MMSE), defined as the time from randomization to decline of MMSE from any cause.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In stereotactic radiotherapy (SRT) of 27-30 Gy in three fractionsfor patients with one to five brain metastases with less than 3.0 cm diameter, an daily irradiation is used in the standard arm while irradiation at two- to three-day intervals is performed in the experimental arm.
Both arms are performed once a daily with total dose of 27-30 Gy in 3 fractions (9-10 Gy per fraction).
Arm 1 (standard arm): consecutive daily irradiation; total SRT duration, 3 days.
Interventions/Control_2
In stereotactic radiotherapy (SRT) of 27-30 Gy in three fractionsfor patients with one to five brain metastases with less than 3.0 cm diameter, an daily irradiation is used in the standard arm while irradiation at two- to three-day intervals is performed in the experimental arm.
Both arms are performed once a daily with total dose of 27-30 Gy in 3 fractions (9-10 Gy per fraction).
Arm 2 (experimental arm): irradiation at two- to three-day intervals; total SRT duration, 8 days.
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. Age 20 years or older.
2. Karnofsky Performance Status (KPS) > or = 70.
3. Total number of 1-5 brain metastases by enhanced magnetic resonance imaging (MRI).
4. Brain metastases with less than 3.0 cm diameter by enhanced magnetic resonance imaging (MRI).
5. Willing to provide informed consent.
Key exclusion criteria
1. The histological type of the primary site is small cell lung cancer, lymphoma, and germ cell tumor.
2. Metastases of the brainstem.
3. Meningeal carcinomatosis.
4. Substantial overlap with a previously treated radiation volume.
5. Surgical history for brain metastases.
6) Difficult to be enrolled to the study by reason of insanity.
7. In pregnancy or with expectation of pregnancy.
8. Inability to use enhancing agent for MRI due to low renal function or allergy.
9. A physician dismiss as subject of the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Natsuo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya City University Hospital
Division name
Radiation Oncology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL
052-853-8276
c051728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Natsuo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya City University Hospital
Division name
Radiation Oncology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL
052-851-5511
Homepage URL
c051728@yahoo.co.jp
Sponsor or person
Institute
Radiation Oncology, Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
1.Japan Society for the Promotion of Science (JSPS) KAKENHI.
2.Hori Science and Arts Foundation
3.Grant-in-aid for research on radiation oncology of JASTRO 2021-2022
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
The institutional review board of Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
Tel
052-851-5511
irb_jimu@med.nagoya-cu.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
1. 名古屋市立大学病院(愛知県）
2. 北里大学病院(東京都）
3. 岐阜大学医学部附属病院(岐阜県）
4. 愛知医科大学病院(愛知県）
5. 名古屋市立大学医学部附属東部医療センター(愛知県）
6. 名古屋市立大学医学部附属西部医療センター(愛知県）
7. 日本赤十字社愛知医療センター名古屋第二病院(愛知県）
8. 一宮市立市民病院(愛知県）
9. 名古屋掖済会病院(愛知県）
10.岡崎市民病院(愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055515
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