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A clinical trial for neoadjuvant stereotactic radiosurgery before surgery resection of large brain metastasis

A clinical trial for neoadjuvant stereotactic radiosurgery before surgery resection of large brain metastasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038995
Enrollment
Unknown
Registered
2020-10-12
Start date
2021-01-07
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Brain Metastasis

Interventions

experimental group:Neoadjuvant stereotactic radiosurgery before surgery

Sponsors

The First Affiliated Hospital of Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients older than or equal to 18 years old; 2. Patients with a history of histologically confirmed primary malignant tumor are required; 3. Patients with Karnofsky status score (KPS) greater than or equal to 60; 4. Patients with life expectancy greater than 12 weeks (predicted by DS GPa or GPA); 5. Patients with newly diagnosed brain metastases (1-4 solid brain tumors were found by enhanced MRI or CT scan within 30 days of the start of the study, and at least one brain metastases with a maximum diameter of 2-5cm was considered as suitable for surgical resection by neurosurgeons; if there were multiple lesions, the total volume of brain metastases was no more than 30 cm3 except for the lesions to be removed, and the rest tumors were suitable for SRS treatment); 6. Subjects who understand and are willing to sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with lymphoma, small cell carcinoma and germinoma as primary tumors; 2. Patients with leptomeningeal metastasis (MR or CSF evaluation); 3. Patients with pre hernia or near death state or status epilepticus or severe mental disorder; 4. The fourth ventricle is compressed and hydrocephalus is obvious in the patients whose tumor location is adjacent to myopic nerve or brain stem; 5. Patients with more than 4 brain metastases on head MR or CT, or the maximum diameter of tumor is more than 5 cm; 6. Patients with previous WBRT history or resected lesions who have received radiotherapy; 7. Patients receiving anti VEGF treatment within 6 weeks before SRS; 8. Those patients with contraindications to general anesthesia; 9. Patients with contraindications of MRI scan or enhanced scan; 10. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
The incidence of >= symptomatic grade 2 radiation toxicity in patients receiving neoadjuvant stereotactic radiosurgery before surgery with in one year.;

Secondary

MeasureTime frame
The local control rate of tumor within one year.;The incidence of leptomeningeal metastases within one year.;Median survival time.;Progression free survival;The treatment rate of salvage therapy.;

Countries

China

Contacts

Public ContactTong Ying

The First Affiliated Hospital of Medical College of Zhejiang University

1194054@zhu.edu.com+86 138 5803 8849

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026