Health TrialsbyHealthPanel

RAPid SimPLE Targeted Radiation Treatment for Brain Metastases

ConditionBrain Metastases, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBritish Columbia Cancer Agency

About this trial

The aim of the study is to show that rapid, simple targeted radiotherapy to brain metastases with 8 Gy / 1 is non-inferior to 20 Gy / 5 in terms of overall survival for patients with poor prognosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

Pathological diagnosis of a non-hematopoietic malignancy

Brain metastases of any size

Any number of untreated or progressing, previously treated brain metastases that can all be contoured and targeted

Disqualifiers

Inability to have a brain MRI

WBRT less than 3 months prior to randomization

Disseminated leptomeningeal carcinomatosis (limited pachymeningeal disease is permitted)

Multiple sclerosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeting All Brain Metastases

    Radiation

    Volumetric Modulated Arc Therapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain MetastasesActive comparator 1 intervention
Group B: 8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain MetastasesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival Time

The median time from randomization to death

Time frame
1 year

Secondary outcomes

1

Median Time to Decline in Karnofsky Performance Status

The time from randomization to a 20-point decline in Karnofsky Performance Status

Time frame
1 year
2

Control of treated brain metastases

Cumulative incidence of local recurrence of treated metastases

Time frame
1 year
3

Corticosteroid use

Proportion of patients taking corticosteroids

Time frame
6 weeks
4

Control of brain disease

Cumulative incidence of (local recurrence of treated metastases OR new metastases)

Time frame
1 year

Other outcomes

Sponsors and contacts

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

British Columbia Cancer Agency

Lead sponsor

Varian Medical Systems

Collaborator

Source ClinicalTrials.gov
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