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Radiation before or after surgery for large brain metastases

Compares radiosurgery given before versus after surgery in adults with large brain metastases.

Key facts

Who runs it
Istituto Clinico Humanitas
Where
Italy9 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
Status
Recruiting
People taking part
146 people, planned
Started
31 Jan 2023
Expected to end
Jan 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Hypofractionated Radiosurgery (HSRS)
  • Brain metastases surgical resection
Record updated
30 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with 1 to 4 brain metastases from a solid tumor who need surgery to remove one of them. It compares focused radiation given before surgery with radiation given after surgery.

Age
Over 18 years.
Sex
All sexes.
Disease stage
Solid tumor that has spread to the brain, with 1-4 brain metastases. One lesion must be at least 2.1 cm (0.8 in) across (4 cm3), or a lesion of 2 cm (0.8 in) or less that presses on the brain, causes nerve problems, or causes heavy swelling that steroids do not help. Spread outside the brain must be controlled or responding to treatment. Karnofsky performance status (KPS) of 70 or more.
Earlier treatment
People cannot join if they had whole-brain radiation (WBRT) before, or earlier open brain surgery for cancer.

Main reasons for not taking part

  • Small cell lung cancer, germ cell tumor, or lymphoproliferative disease (cancers of the lymph system)
  • More than 4 brain metastases
  • KPS below 70
  • Pregnant women
  • Unable to have an MRI scan

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Age >18 years
  • Histological or cytological or radiological confirmation of solid tumor malignancy
  • Clinical indication for surgical resection of one brain metastasis
  • Karnosky performance status (KPS) ≥70
  • Controlled or responsive extra cranial metastatic lesions
  • Limited brain metastases (1-4 BMs)
  • Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3)
  • Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids
  • Written informed consent form

Who cannot take part

  • Prior WBRT
  • Prior open neurosurgery for malignancy
  • Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease
  • KPS < 70
  • Pregnant women
  • More than 4 brain metastases
  • Patients with incompatibility to perform MRI

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.

The 2 groups in the trial

  • HSRS pre-operativeTreatment being tested

    Patients undergo HSRS (hypofractionated Radiosurgery) on day 1, consisting in 27 Gray (gy) administered in 3 daily fractions. Within 1 weeks, patients undergo surgical resection.

    Treatment: Hypofractionated Radiosurgery (HSRS) and Brain metastases surgical resection

  • HSRS post-operativeExisting treatment, for comparison

    Patients undergo surgical resection on day 1. Within 4-6 weeks, patients undergo HSRS (hypofractionated Radiosurgery), consisting in 27 Gray (gy) administered in 3 daily fractions.

    Treatment: Hypofractionated Radiosurgery (HSRS) and Brain metastases surgical resection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection
Plain-language title
Radiation before or after surgery for large brain metastasesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
30 April 2026