Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer

Last updated: July 9, 2025
Sponsor: Australasian Gastro-Intestinal Trials Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abdominal Cancer

Peritoneal Cancer

Treatment

Intervention: MRI-Linac SABR

Clinical Study ID

NCT06604533
MR-STAR
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older

  • Patients with diagnosis of oligometastatic disease from primary colorectal, uppergastrointestinal (e.g. gastric, oesophagus, pancreatic), breast, non-small celllung, renal cell, or gynaecological malignancy. Oligometastatic disease withcontrolled primary disease* and maximum total of 5 metastatic lesions in a maximumof 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 hasbeen treated with curative intent.

  • Controlled primary disease in metachronous oligometastastic disease defined asat least 3 months since original tumour treated with curative intent and noprogression at primary site

  • Controlled primary disease in de novo oligometastatic disease defined asprimary tumour site treated with curative intent and no progression at primarysite

  • Oligometastatic disease: Histological confirmation of primary malignancy (histological confirmation of metastasis is not mandatory but should be performed inany 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 2oligo-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

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 SABRor high dose radiotherapy is not permitted in this trial.

  • Substantial overlap with a previously treated high dose (definitive or stereotacticdose) radiation volume.

  • Primary prostate cancer, carcinoid tumours, germ cell tumours, lymphoma, small celltumours

  • Pregnant women

  • Complete response of metastatic disease to systemic therapy (i.e. no target forSABR)

  • Competing medical co-morbidity with a more limited prognosis than the cancerdiagnosis

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Intervention: MRI-Linac SABR
Phase:
Study Start date:
July 07, 2025
Estimated Completion Date:
November 30, 2027

Study 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 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.

Connect with a study center

  • GenesisCare - St Vincent's Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • GenesisCare Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Austin Health

    Melbourne, Victoria 3084
    Australia

    Site Not Available

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