RecruitingNot ApplicableNCT06604533

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

A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer


Sponsor

Australasian Gastro-Intestinal Trials Group

Enrollment

30 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria19

  • 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 Criteria7

  • 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

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Interventions

PROCEDUREIntervention: MRI-Linac SABR

The treatment planning protocol follows the UK SABR Consortium Guidelines. Patients will be prescribed the maximum isotoxic dose achievable while meeting normal organ tolerances (normal liver, kidney, spinal cord, stomach, duodenum, small and large bowel, heart, lungs, chest wall). The lowest acceptable SABR doses are indicated in the dose range Table within the protocol. The maximum dose/fraction also indicates the maximum the dose can be escalated to for each adaptive session on the MRI-Linac.


Locations(2)

GenesisCare - St Vincent's Sydney

Darlinghurst, New South Wales, Australia

Austin Health

Melbourne, Victoria, Australia

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NCT06604533


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