Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial

This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.

Study Overview

• Status: Completed
• Conditions: Brain Metastases, Adult
• Intervention / Treatment: Radiation: fractionated stereotactic radiotherapy

Detailed Description

This study plans to enroll 48 patients with 1-4 brain metastases with ≤2cm in diameter. All of the patients will receive FSRT with the dose of 30 Gy in 5 fractions. The primary endpoint is local control rate of asymptomatic brain necrosis at 1 year. The secondary endpoints include disease control rate at 2 months, local control rate at 1 year, intra-cranial distant failure at 1 year, overall survival rate at 1 year, toxicities, radiation necrosis rate, etc.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Ye Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The primary tumor is proved malignant by pathology;
2. Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
3. The maximum diameter of each lesion is ≤ 2cm;
4. Age ≥ 18 years old;
5. KPS≥ 70;
6. Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT);
7. expected survival of more than 6 months;
8. The functions of vital organs meet the requirements;
9. The patients voluntarily join the clinical study and sign the informed consent.

Exclusion Criteria:

1. Surgical intervention is considered for MDT consultation;
2. Meningeal metastasis;
3. The primary tumor is small cell lung cancer;
4. Follow-up data can't be obtained regularly;
5. patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by color doppler examination;
6. neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months;
7. Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fractionated stereotactic radiotherapy group; fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions.	Radiation: fractionated stereotactic radiotherapy; The prescription is 30 Gy in 5 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local control without symptomatic radiation necrosis rate	radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.	1 year after fractionated stereotactic radiotherapy (FSRT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease control rate	Complete release (CR) + partial release (PR) + stable disease (SD) rate, assessed by RECIST 1.1 criteria	2 months after fractionated stereotactic radiotherapy (FSRT)
local control rate	local control rate of the lesions which received FSRT	1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial distant failure rate	new brain metastases in the brain	1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial progression free survival rate	local control without intra-cranial distant failure	1 year after fractionated stereotactic radiotherapy (FSRT)
adverse events	neurological toxicity was determined according to RTOG acute toxicity classification criteria, and the rest was determined according to NCI-CTCAE V5.0 criteria	From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.
radiation necrosis rate	radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.	From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Ye Zhang, MD., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: fractionated stereotactic radiotherapy; limited brain metastases; small brain metastases
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: NCC-012829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD is protected by our institution and are not allowed to share to others.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No