Save

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

NOT_YET_RECRUITING

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.

Simpliy with AI

Study details:

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-11-01

Primary completion: 2026-11-01

Study completion finish: 2027-11-01

Study type

TREATMENT

Phase

Trial ID

NCT06604533

Intervention or treatment

PROCEDURE: Intervention: MRI-Linac SABR

Conditions

• Abdominal Cancer

Condition: Abdominal Cancer
PROCEDURE: Intervention: MRI-Linac SABR
Melbourne, Victoria, Australia and more
Sponsor: Australasian Gastro-Intestinal Trials Group

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Health

Research sites nearby

Select from list below to view details:

Austin Health
Melbourne, Victoria, Australia
GenesisCare Sydney
Darlinghurst, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intervention: 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.	PROCEDURE: Intervention: 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.
NO_INTERVENTION: Control: Standard 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.	Not specified

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Intervention: 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.

PROCEDURE: Intervention: 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.

NO_INTERVENTION: Control: Standard 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.

Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.

Secondary outcome

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer