Clinical trial NCT06604533: Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Official title: A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Cancer
Lead sponsor: Australasian Gastro-Intestinal Trials Group
Sponsor class: NETWORK
Collaborators: name: Trans Tasman Radiation Oncology Group
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Rate of local control (Local Response Rate).
timeFrame: Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: GenesisCare Sydney
state: New South Wales
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: South Western Sydney LHD
name: Trang Pham
role: STUDY_CHAIR
References: