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New treatment option for Liver Metastases
Official title Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction
ClinicalTrials.gov ID: NCT06362395
What this study is testing
- What it's testing
- This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.
- Phase 3: a large, late-stage study
- 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
- Histologically confirmed malignancy (colorectal adenocarcinoma, pancreatic adenocarcinoma, head and neck SCC, cervix SCC, skin SCC and NSCLC) with...
- One, two or three liver metastases "target lesion", ≥ 2 cm from luminal and biliary structures
- Target lesions(s) that can receive high/ultra-high dose SBRT: Maximum number: 3, Maximum diameter of each target lesion: 6cm
- Non-target lesion(s) can be treated with 3- or 5-fraction SBRT for non-target liver metastases
- Patients must be Child-Pugh score A within one month prior to study entry.
You likely can't join if
- Liver metastases from primary cancer other than listed in the eligibility criteria (i.e., tumor with low α/β ratio).
- Target lesion "planned for high/ultra-high dose SBRT" in proximity (\<2cm) to luminal or biliary structures.
- Evidence of \> 5 liver metastases (exception is in cases of oligoprogression, patients may have more than 5 liver metastases, but SBRT for target...
- Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.
- Previous liver-directed transarterial radioembolization (note that previous transarterial chemoembolization, microwave ablation, or radiofrequency...
- Individuals with severe, active co-morbidity including any of the following:
See the full eligibility criteria
Who can join
- Histologically confirmed malignancy (colorectal adenocarcinoma, pancreatic adenocarcinoma, head and neck SCC, cervix SCC, skin SCC and NSCLC) with metastatic liver disease detected on imaging. Biopsy of metastasis is...
- One, two or three liver metastases "target lesion", ≥ 2 cm from luminal and biliary structures
- Target lesions(s) that can receive high/ultra-high dose SBRT: Maximum number: 3, Maximum diameter of each target lesion: 6cm
- Non-target lesion(s) can be treated with 3- or 5-fraction SBRT for non-target liver metastases
- Patients must be Child-Pugh score A within one month prior to study entry.
- Must be ≥ 18 years of age.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected life expectancy \> 6 months.
- Suitable for MR-linac treatment (e.g., ability to lie on the treatment couch for at least one hour)
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to...
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in English. The baseline assessment must be completed within required timelines, prior to treatment start. Inability...
- Women of child bearing potential must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 6 months after the last day of RT. Sexually...
- Women must not be pregnant or breast-feeding. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should...
What rules you out
- Liver metastases from primary cancer other than listed in the eligibility criteria (i.e., tumor with low α/β ratio).
- Target lesion "planned for high/ultra-high dose SBRT" in proximity (\<2cm) to luminal or biliary structures.
- Evidence of \> 5 liver metastases (exception is in cases of oligoprogression, patients may have more than 5 liver metastases, but SBRT for target lesions will be required for 1, 2, or 3 liver metastases only).
- Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.
- Previous liver-directed transarterial radioembolization (note that previous transarterial chemoembolization, microwave ablation, or radiofrequency ablation are permitted).
- Individuals with severe, active co-morbidity including any of the following:
- Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration
- Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration
- Acute myocardial infarction within 30 days of study registration
- Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease)
- Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical...
- History of claustrophobia
- The total length of treatment volume is beyond the capacity of MRL machine
- Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with SBRT (≥1 week break of systemic therapy prior to SBRT is required).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 Toronto, Ontario, Canada. 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.