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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048728

Enrollment

Registered

2022-09-01

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain metastasis

Interventions

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 i

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

total SRT duration, 8 days.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Intracranial local control rate (IC-LC), defined as intracranial local control at initially treated sites.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactNatsuo Tomita

Nagoya City University Hospital Radiation Oncology

c051728@yahoo.co.jp052-851-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026