Actively Recruiting
A Randomized Phase II Trial of MRI-Guided Stereotactic Adaptive Radiotherapy for Abdominal Cancer
Led by Australasian Gastro-Intestinal Trials Group · Updated on 2026-05-08
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Australasian Gastro-Intestinal Trials Group
Lead Sponsor
T
Trans Tasman Radiation Oncology Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of MRI-guided adaptive stereotactic radiotherapy on local control, survival, and side effects in patients with oligometastatic cancer in the abdomen. This Australian-led Phase 2 randomized trial aims to provide high-level evidence on whether this new technology improves patient outcomes and helps select suitable patients for MRI-Linac treatment. The study focuses on abdominal oligometastatic or primary liver cancer and investigates treatment accuracy and potential MRI biomarkers predicting response. Participants will be assigned to either the experimental group receiving MRI-Linac stereotactic ablative body radiotherapy (SABR) or the control group receiving standard SABR. Treatment follows UK SABR Consortium Guidelines, prescribing the highest dose possible without exceeding normal organ limits. The MRI-Linac allows adaptive dose escalation during each session to optimize targeting. Both groups receive treatment tailored to meet organ tolerance limits for liver, kidney, spinal cord, stomach, bowel, heart, lungs, and chest wall. During the study, patients will undergo clinical imaging every three months after radiotherapy for up to three years to monitor local control of lesions. Researchers will assess survival, treatment safety, delivered radiation dose, and treatment targeting accuracy. Functional MRI scans will be explored to identify biomarkers that may predict how tumors respond to radiotherapy. Total participation length varies, with ongoing follow-up imaging and clinical evaluation to measure outcomes.
CONDITIONS
Brief Title
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosis of oligometastatic disease from primary colorectal, upper gastrointestinal, breast, non-small cell lung, renal cell, or gynecological cancer
- Oligometastatic disease with controlled primary cancer and up to 5 metastatic lesions in no more than 2 different organ systems including liver, adrenal, lymph nodes, abdomen, pelvis, bone, or lung in combination with abdominal sites
- De novo or metachronous oligometastatic disease with primary tumor treated with curative intent and no progression at primary site
- Histological confirmation of primary malignancy
- All oligometastatic sites must be treatable with stereotactic ablative radiotherapy (SABR)
- Patients with oligo-progressive or oligo-persistent disease with up to 2 abdominal metastases in no more than 2 organ systems
- Visible targets on imaging suitable for SABR
- Child-Pugh class A to B7 if liver treatment is planned
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Provided informed consent
You will not qualify if you...
- Contraindication to MRI
- Previous high dose radiotherapy to the site planned for stereotactic treatment including SIRTEX
- Overlap with previously treated high-dose radiation volume
- Primary prostate cancer, carcinoid tumors, germ cell tumors, lymphoma, or small cell tumors
- Pregnant women
- Complete response of metastatic disease to systemic therapy with no target lesion for SABR
- Medical conditions limiting prognosis more than the cancer diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on treatment plan and dose escalation protocol
Participants receive stereotactic ablative radiotherapy (SABR) targeting abdominal oligometastatic cancer using MRI-guided adaptive techniques or standard SABR according to random assignment.
Multiple treatment visits according to radiotherapy schedule
Duration - Up to 3 years post radiotherapy
Participants undergo clinical and imaging assessments to monitor local control, survival, and safety for up to 3 years after radiotherapy treatment.
Clinical progress imaging every 3 months until 3 years post treatment
Trial Site Locations
Total: 2 locations
1
GenesisCare - St Vincent's Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
Austin Health
Melbourne, Victoria, Australia, 3084
Not Yet Recruiting
Research Team
S
Sukanya Sathyamurthie
S
Sandra Bahamad
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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