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Trial Title:
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
NCT ID:
NCT06604533
Condition:
Abdominal Cancer
Conditions: Official terms:
Abdominal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Intervention: MRI-Linac SABR
Description:
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.
Arm group label:
Intervention: MRI-Linac SABR
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GenesisCare Sydney
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Contact:
Last name:
Jeremiah De Leon
Phone:
02 8302 5400
Email:
jeremy.deleon@genesiscare.com
Investigator:
Last name:
Jeremiah De Leon
Email:
Principal Investigator
Facility:
Name:
Austin Health
Address:
City:
Melbourne
Zip:
3084
Country:
Australia
Contact:
Last name:
Sweet Ping Ng
Phone:
0412 636 394
Email:
SweetPing.NG@austin.org.au
Investigator:
Last name:
Sweet Ping Ng
Email:
Principal Investigator
Start date:
November 2024
Completion date:
November 2027
Lead sponsor:
Agency:
Australasian Gastro-Intestinal Trials Group
Agency class:
Other
Collaborator:
Agency:
Trans Tasman Radiation Oncology Group
Agency class:
Other
Source:
Australasian Gastro-Intestinal Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06604533
