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

NCT06604533 | Recruiting DMC

• 1 other identifier: MR-STAR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of local control (Local Response Rate).

  To determine if patients treated with MRI guided stereotactic radiotherapy improves local control. Local control is defined as absence of progression in treated lesion(s) and will be measured via clinical progress imaging (and assessed using RECIST criteria).

  Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy.

Study Arms (2)

Intervention: MRI-Linac SABR

EXPERIMENTAL

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.

Procedure: Intervention: MRI-Linac SABR

Control: Standard SABR

NO INTERVENTION

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.

Interventions

Intervention: MRI-Linac SABR PROCEDURE

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.

Intervention: MRI-Linac SABR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Australasian Gastro-Intestinal Trials Group: lead
• Trans Tasman Radiation Oncology Group: collaborator

Study Sites (2)

GenesisCare - St Vincent's Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Austin Health

Melbourne, Victoria, 3084, Australia

NOT YET RECRUITING

Study Officials

• Trang Pham

  South Western Sydney LHD

  STUDY CHAIR

Central Study Contacts

Sukanya Sathyamurthie

CONTACT

+61 2 7208 2719; sukanya@gicancer.org.au

Miriam Roesner

CONTACT

+61 2 7208 2727; miriam@gicancer.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: September 19, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)