Health TrialsbyHealthPanel

Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

ConditionBrain Metastases, Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior WBRT

KPS < 70

Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Brain metastases surgical resection

    Procedure/Surgery

    Complete surgical resection of brain lesions with adeguate margins.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: HSRS pre-operativeExperimental treatment 2 interventions
Group B: HSRS post-operativeActive comparator 2 interventions

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

Rate of local recurrence

To evaluate for patients undergone pre-operative as compared to post-operative HSRS whether there is a decreased rate of local recurrence. This assessment will be evaluated through radiological images.

Time frame
1 year
2

Rate of brain distant progression

To evaluate for patients undergone pre-operative as compared to post-operative HSRS whether there is a decreased rate of brain distant progression. This assessment will be evaluated through radiological images.

Time frame
1 year
3

Overall Survival

To evaluate for patients with brain metastases whether there is improved overall survival for patients who receive HSRS prior to surgery as compared to patients who receive HSRS after surgery.

Time frame
1 year
4

Radiation Necrosis Evaluation

To evaluate for patients undergone pre-operative as compared to post-operative HSRS whether there is a decreased rate of symptomatic radiation necrosis (RN). RN will be evaluated through radiological images.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Clinico Humanitas

Lead sponsor

Brainlab AG

Collaborator

Source ClinicalTrials.gov
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