two-session fractionated stereotactic radiotherapy

JRCT ID: jRCT1052240177

Registered date:05/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: brain metastases
• Date of first enrollment: 18/09/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): two-session fractionated stereotactic radiotherapy

Outcome(s)

• Primary Outcome: Rate of late adverse events at 6 months (CTCAE 5th edition grade 2 or higher)
• Secondary Outcome: Local control rate, rate of acute phase adverse events (CTCAE 5th edition grade 2 or higher), survival, intracranial distant recurrence rate, and rate of quality of life deterioration at the site of two-stage stereotactic radiotherapy at 6 months after treatment initiation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Age is 20 years or older
(2) The primary tumor and metastases must be lung cancer or breast cancer
(3) The patient must have at least one metastatic brain tumor with a maximum diameter of at least 15 mm and less than 30 mm (multiple brain metastases with a maximum diameter of less than 15 mm are acceptable)
(4) Performance status (PS) 0, 1, or 2, or PS 3 due to tumor-related neurological symptoms only
(5) No meningeal dissemination
(6) No history of radiation therapy for intracranial lesions

• Exclude criteria: Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.

Related Information

• Primary Sponsor: Mizowaki Takashi
• Source(s) of Monetary Support: JSPS KAKENHI Grant