NCT05545007

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Jan 2027

First Submitted

Initial submission to the registry

September 6, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

September 6, 2022

Last Update Submit

April 24, 2026

Conditions

Brain Metastases, Adult

Keywords

pre-operative hypofractionated radiosurgerysurgical resectionlarge brain metastasespost-operative hypofractionated radiosurgery

Outcome Measures

Primary Outcomes (1)

  • Rate of LMD (leptomeningeal disease) occurrence

    Rate of LMD occurrence in patients who receive HSRS prior to surgery as compared to patients who receive HSRS after surgery. This assessment will be evaluated through radiological images.

    1 year

Secondary Outcomes (6)

  • Rate of local recurrence

    1 year

  • Rate of brain distant progression

    1 year

  • Overall Survival

    1 year

  • Radiation Necrosis Evaluation

    1 year

  • Rate of surgical Morbidity

    1 year

  • +1 more secondary outcomes

Study Arms (2)

HSRS pre-operative

EXPERIMENTAL

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.

Radiation: Hypofractionated Radiosurgery (HSRS)Procedure: Brain metastases surgical resection

HSRS post-operative

ACTIVE COMPARATOR

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.

Radiation: Hypofractionated Radiosurgery (HSRS)Procedure: Brain metastases surgical resection

Interventions

Hypofractionated Radiosurgery (HSRS)RADIATION

HSRS converges multiple radiation beams to deliver a single, large dose of radiation to a discrete tumor target with high precision, thereby minimizing radiation dose to the surrounding normal tissue.

HSRS post-operativeHSRS pre-operative
Brain metastases surgical resectionPROCEDURE

Complete surgical resection of brain lesions with adeguate margins.

HSRS post-operativeHSRS pre-operative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ASST Spedali Civili di Brescia

Brescia, Brescia, 25123, Italy

RECRUITING

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, 50134, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milan, 20133, Italy

RECRUITING

Ospedale del Mare

Naples, Naples, 80147, Italy

RECRUITING

Policlinico Umberto I

Rome, Rome, 00161, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Rome, 00168, Italy

RECRUITING

AOU Sant'Andrea

Rome, Rome, 00189, Italy

RECRUITING

Azienda Ospedaliera Santa Maria di Terni

Terni, Terni, 05100, Italy

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Pierina Navarria, MD

CONTACT

+39 028224 7458pierina.navarria@cancercenter.humanitas.it

Federico Pessina, MD

CONTACT

+39 028224 4617federico.pessina@hunimed.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 19, 2022

Study Start

January 31, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations

IT(9)