REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion > 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
≥ 18 years old at time of study enrollment
Child-Pugh A status
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Disqualifiers
Prior treatment with radioembolization
Cytotoxic chemotherapy or investigational agent within 1 week of SABR
Prior radiotherapy overlapping with study treatment site
Female patients who are pregnant
Trial design
Design model
Single group
Treatments tested in this trial
MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
RadiationA single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40 Gy delivered in one fraction using external beam techniques.
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1-year Overall Survival (OS)
Overall survival will be defined as the time from treatment to death from any cause. Patients alive at the time of analysis will be censored at last follow-up.
Time frame
1 year after SABRSecondary outcomes
1
Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events
Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 gastrointestinal adverse events (including fatigue, nausea, diarrhea, or GI pain) attributable to SABR.
Time frame
Within 90 days of completing SABR2
Rate of Grade ≥ 2 Radiation Pneumonitis
Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 radiation pneumonitis attributable to SABR.
Time frame
Within 90 days of completing SABR3
Rate of Grade ≥ 2 Chest Wall Toxicity
Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 chest wall toxicity attributable to SABR.
Time frame
Within 90 days of completing SABR4
Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR
Patient-reported global health status and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, with higher scores indicating better global health status and overall quality of life.
Time frame
Up to 1 year post-SABRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Viewray Inc.
Collaborator
Source ClinicalTrials.gov