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Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on local control, survival, and toxicity in the treatment of oligometastatic cancer to the abdomen.
Study details:
This is an Australian-led multi-centre Phase 2 randomised controlled trial. The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on LC, survival, and toxicity in the treatment of oligometastatic cancer to the abdomen. This study will provide one of the first high level phase 2 randomised evidence required to demonstrate this new technology improves patient clinical outcomes and inform the selection of patients for MRI-Linac treatment.
The primary objective is to evaluate the effect of MRI-guided adaptive stereotactic radiotherapy on 2 year LC of treated lesion(s) in patients with abdominal oligometastatic or primary liver cancer. Aim 1: Quantify the effect of MRI-guided stereotactic radiotherapy on patient outcomes. Patient outcomes will be determined by measuring LC, survival, and safety (toxicity).
Aim 2: Quantify patient dose and cancer targeting accuracy. The ability of MRI-Linacs to treat more patients to a higher dose than standard linacs through adaptive dose-escalation and improved target coverage will be quantified. The delivered dose for each treatment arm will be compared.
Aim 3: Explore functional MRI biomarkers of radiotherapy response prediction. Candidate functional biomarkers of tumour perfusion and diffusion will be identified.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-11-01
Primary completion: 2026-11-01
Study completion finish: 2027-11-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT06604533
Intervention or treatment
PROCEDURE: Intervention: MRI-Linac SABR
Conditions
- • Abdominal Cancer
Find a site
Closest Location:
Austin Health
Research sites nearby
Select from list below to view details:
Austin Health
Melbourne, Victoria, Australia
GenesisCare Sydney
Darlinghurst, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Intervention: MRI-Linac SABR
| PROCEDURE: Intervention: MRI-Linac SABR
|
NO_INTERVENTION: Control: Standard SABR
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Rate of local control (Local Response Rate). | To determine if patients treated with MRI guided stereotactic radiotherapy improves local control. Local control is defined as absence of progression in treated lesion(s) and will be measured via clinical progress imaging (and assessed using RECIST criteria). | Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy. |
Secondary outcome
Frequently Asked Questions
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