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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
20/09/2024

Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Scientific title
A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Secondary ID [1] 0 0
MR-STAR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Cancer 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of local control (Local Response Rate).
Timepoint [1] 0 0
Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GenesisCare Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Gastro-Intestinal Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06604533
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Trang Pham
Address 0 0
South Western Sydney LHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sukanya Sathyamurthie
Address 0 0
Country 0 0
Phone 0 0
+61 2 7208 2719
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06604533