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New treatment option for Metastatic Cancer
Official title Ablative Radiotherapy to Restrain Every Metastasis Safely Treatable (ARREST-2): A Randomized Phase II/III Trial
ClinicalTrials.gov ID: NCT05508464
What this study is testing
- What it's testing
- This is a phase II/III international multicentre randomized trial. Patients will be randomized in a 1:2 ratio between the standard of care (Arm 1) and SABR (Arm 2) to all sites of disease.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 or older
- willing and able to provide informed consent
- ECOG performance status 0-2
- Life expectancy \> or equal to 6 months
- Histologically confirmed malignancy with evidence of metastatic disease on imaging
You likely can't join if
- Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Chrohn's...
- For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)
- Substantial overlap with a previously treated radiation volume. Prior radiotherapy is allowed, as long as the composite plan meets dose constraints...
- Inability to treat all sites of disease. Any brain metastasis \>3 cm in size or a total volume of brain metastases greater than 30 cc.
- Solitary or dominant brian metastasis requiring surgical decompression.
- Radiologic evidence of spinal cord compression.
See the full eligibility criteria
- Age 18 or older
- willing and able to provide informed consent
- ECOG performance status 0-2
- Life expectancy \> or equal to 6 months
- Histologically confirmed malignancy with evidence of metastatic disease on imaging
- All sites of disease can be safely treated on a preliminary radiation plan
- \> or equal to 11 metastases (the primary tumor does not have to be controlled and can be included as a target if it can feasibly and safely be treated with SABR. If the primary tumor is treated, a minimum of 12 targets...
- Investigations required within 12 weeks of enrollment:
- Brain: MRI is required for all patients with known untreated or previously treated brain metastases. MRI is strongly recommended for all tumor sites with a propensity to develop brian metastases.
- Body: 18-FDG PET/CT imaging is recommended, except for tumors where FDG uptake is not expected (e.g. prostate, renal cell carcinoma). PSMA-PET or choline-PET is recommended for prostate cancer. In situations where a PET...
- Liver: For patients with liver metastases, a diagnostic or simulation MRI is required to confirm the total number of metastases.
- No plans for systemic therapy (i.e. chemotherapy, targeted agent, immunotherapy) for 3 months from the time of enrolment. Reasons may include: a break from systemic therapy is desired by the patient and medical...
- SABR or palliative radiotherapy should commence no later than 2 weeks after randomization.
- For patients with brain metastases that are going to be treated regardless of the study arm, there must be additional extracranial disease present that will be treated with SABR on Arm 2 and not treated with SABR on Arm...
- Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Chrohn's disease in patients where the GI tract will receive radiotherapy...
- For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)
- Substantial overlap with a previously treated radiation volume. Prior radiotherapy is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biologically...
- Inability to treat all sites of disease. Any brain metastasis \>3 cm in size or a total volume of brain metastases greater than 30 cc.
- Solitary or dominant brian metastasis requiring surgical decompression.
- Radiologic evidence of spinal cord compression.
- Disseminated disease, including leptomeningeal metastases, peritoneal metastases/carcinomatosis, malignant pleural effusion, and lymphangitis carcinomatosis.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
- Montreal, Quebec, Canada
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada; Montreal, Quebec, Canada; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.