Unique ID issued by UMIN | UMIN000048728 |
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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 |
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
Consecutive vs intervals-BM SRT
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
Consecutive vs intervals-BM SRT
Japan |
Brain metastasis
Radiology |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Intracranial local control rate (IC-LC), defined as intracranial local control at initially treated sites.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
2
Treatment
Device,equipment |
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.
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.
20 | years-old | < |
Not applicable |
Male and Female
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.
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.
70
1st name | Natsuo |
Middle name | |
Last name | Tomita |
Nagoya City University Hospital
Radiation Oncology
4678601
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
052-853-8276
c051728@yahoo.co.jp
1st name | Natsuo |
Middle name | |
Last name | Tomita |
Nagoya City University Hospital
Radiation Oncology
4678601
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
052-851-5511
c051728@yahoo.co.jp
Radiation Oncology, Nagoya City University Hospital
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
Japanese Governmental office
The institutional review board of Nagoya City University Graduate School of Medical Sciences
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
052-851-5511
irb_jimu@med.nagoya-cu.ac.jp
NO
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)
2022 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2022 | Year | 07 | Month | 15 | Day |
2022 | Year | 08 | Month | 02 | Day |
2022 | Year | 09 | Month | 01 | Day |
2027 | Year | 03 | Month | 31 | Day |
2022 | Year | 08 | Month | 23 | Day |
2022 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055515
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