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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06604533
Registration number
NCT06604533
Ethics application status
Date submitted
8/07/2024
Date registered
19/09/2024
Date last updated
11/07/2025
Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
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Scientific title
A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
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Secondary ID [1]
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MR-STAR
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Abdominal Cancer
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Intervention: MRI-Linac SABR
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.
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.
Treatment: Surgery: 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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of local control (Local Response Rate).
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Assessment method [1]
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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).
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Timepoint [1]
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Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy.
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Eligibility
Key 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.
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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GenesisCare - St Vincent's Sydney - Darlinghurst
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Recruitment hospital [2]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australasian Gastro-Intestinal Trials Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Trans Tasman Radiation Oncology Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06604533
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Trang Pham
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Address
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South Western Sydney LHD
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sukanya Sathyamurthie
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Address
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Country
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Phone
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+61 2 7208 2719
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06604533
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