Status:
RECRUITING
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Lead Sponsor:
Australasian Gastro-Intestinal Trials Group
Collaborating Sponsors:
Trans Tasman Radiation Oncology Group
Conditions:
Abdominal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 tox...
Eligibility Criteria
Inclusion
- 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:
- Liver
- Adrenal
- Abdomino-pelvic lymph node
- Other abdominal site e.g. pancreatic, renal.
- Other pelvic site
- 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
- 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
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06604533
Start Date
July 7 2025
End Date
January 1 2030
Last Update
November 17 2025
Active Locations (2)
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1
GenesisCare - St Vincent's Sydney
Darlinghurst, New South Wales, Australia, 2010
2
Austin Health
Melbourne, Victoria, Australia, 3084