REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Phase 2RecruitingNCT07223307

Stanford University62 enrolled

Overview

Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cancer Intrahepatic Cholangiocarcinoma Liver Metastases HCC

Interventions

MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)RADIATION

A 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Life Expectancy \> 6 months * For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done. * Ability to understand and the willingness to provide written informed consent. * Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria Exclusion Criteria: * 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 * Contraindication to having an MRI scan or inability to tolerate MRI * Presence of a pacemaker or other implanted cardiac device * Direct tumor extension into the stomach, duodenum, small bowel or large bowel * Patient unable to breath hold \> 15 seconds

Locations (1)

Stanford University

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

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 SABR

Secondary Outcomes

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 SABR

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 SABR

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 SABR

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-SABR

Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR

Patient-reported quality of life will be evaluated using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep consists of the FACT-General (FACT-G) plus additional hepatobiliary-specific items. Total scores range from 0 to 180, with higher scores indicating better health-related quality of life.

Central Contacts

Eleanor Brown

CONTACT

650-497-8966 eleanor9@stanford.edu

Data from ClinicalTrials.gov

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