Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

NCT07405047 | Completed

• 1 other identifier: NCC-012829
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Metastases, Adult

Keywords

limited brain metastases; small brain metastases; fractionated stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• disease control rate

  2 months after fractionated stereotactic radiotherapy (FSRT)

• local control rate

  1 year after fractionated stereotactic radiotherapy (FSRT)

• intra-cranial distant failure rate

  1 year after fractionated stereotactic radiotherapy (FSRT)

• intra-cranial progression free survival rate

  1 year after fractionated stereotactic radiotherapy (FSRT)

• adverse events

  From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.

Study Arms (1)

fractionated stereotactic radiotherapy group

EXPERIMENTAL

fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions.

Radiation: fractionated stereotactic radiotherapy

Interventions

fractionated stereotactic radiotherapy RADIATION

The prescription is 30 Gy in 5 fractions.

fractionated stereotactic radiotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Surgical intervention is considered for MDT consultation;
• Meningeal metastasis;
• The primary tumor is small cell lung cancer;
• Follow-up data can't be obtained regularly;
• 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;
• neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months;
• Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Ye Zhang

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ye Zhang, MD.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: February 12, 2026
• Study Start: September 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)