MRI-guided adaptive stereotactic radiotherapy for abdominal cancer
A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
This study will try MRI-guided adaptive stereotactic radiotherapy (MRI-Linac SABR) to see if it improves local control, survival, and reduces side effects for adults with up to five abdominal oligometastatic lesions or primary liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Australasian Gastro-Intestinal Trials Group Research network |
| Drugs / interventions | radiation |
| Locations | 2 sites (Darlinghurst, New South Wales and 1 other locations) |
| Trial ID | NCT06604533 on ClinicalTrials.gov |
What this trial studies
This Australian-led, multi-center phase 2 randomized trial compares MRI-guided adaptive stereotactic radiotherapy using an MRI-Linac with standard radiotherapy approaches for patients with abdominal oligometastatic or primary liver cancer. Participants are randomized to receive stereotactic ablative body radiotherapy delivered with MRI guidance and adaptive planning to permit dose escalation and improved target coverage. The primary endpoint is 2-year local control of treated lesions, with secondary endpoints including overall survival, toxicity, delivered dose, and targeting accuracy. The study will also explore functional MRI biomarkers of tumor perfusion and diffusion as predictors of radiotherapy response.
Who should consider this trial
Good fit: Adults (≥18 years) with oligometastatic abdominal disease (maximum five metastatic lesions in up to two organ systems) from specified primaries or with primary liver cancer and with controlled primary disease are the intended candidates.
Not a fit: Patients with widespread metastases beyond the specified limits, uncontrolled primary tumors, contraindications to MRI (such as incompatible implants), or poor performance status are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, MRI-guided adaptive SABR could allow higher, more accurate radiation doses to abdominal tumors, improving local control and survival while reducing toxicity.
How similar studies have performed: Early nonrandomized and single-arm series of MRI-guided SABR have shown promising dosimetric and local control results, but randomized evidence is limited and this trial aims to provide higher-level data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Patients with diagnosis of oligometastatic disease from primary colorectal, upper gastrointestinal (e.g. gastric, oesophagus, pancreatic), breast, non-small cell lung, renal cell, or gynaecological malignancy. Oligometastatic disease with controlled primary disease\* and maximum total of 5 metastatic lesions in a maximum of 2 different organ systems in any of the following sites: 1. Liver 2. Adrenal 3. Abdomino-pelvic lymph node 4. Other abdominal site e.g. pancreatic, renal. 5. Other pelvic site 6. Bony or lung is allowed only if in conjunction with an abdominal site above * De novo or metachronous oligometastatic disease where the original tumour site has been treated with curative intent. * Controlled primary disease in metachronous oligometastastic disease defined as at least 3 months since original tumour treated with curative intent and no progression at primary site * Controlled primary disease in de novo oligometastatic disease defined as primary tumour site treated with curative intent and no progression at primary site * Oligometastatic disease: Histological confirmation of primary malignancy (histological confirmation of metastasis is not mandatory but should be performed in any situation where there is any diagnostic uncertainty). * All oligometastatic sites treatable with SABR. OR * Patients with oligo-progressive / oligo-persistent disease in maximum total of 2 oligo-progressive abdominal metastases and in a maximum 2 different organ systems * Visible imaging defined targets and suitable for treatment with SABR * Childs Pugh A to B7 (in case of liver treatment) * ECOG 0 -2 * Patient consented Exclusion Criteria: * Contra-indication to MRI * Previous high dose radiotherapy to a site requiring stereotactic treatment (including SIRTEX). Further SABR treatment of lesions previously treated with SABR or high dose radiotherapy is not permitted in this trial. * Substantial overlap with a previously treated high dose (definitive or stereotactic dose) radiation volume. * Primary prostate cancer, carcinoid tumours, germ cell tumours, lymphoma, small cell tumours * Pregnant women * Complete response of metastatic disease to systemic therapy (i.e. no target for SABR) * Competing medical co-morbidity with a more limited prognosis than the cancer diagnosis
Where this trial is running
Darlinghurst, New South Wales and 1 other locations
- GenesisCare - St Vincent's Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
- Austin Health — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Sukanya Sathyamurthie
- Email: sukanya@gicancer.org.au
- Phone: +61 2 7208 2719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.