HCC, Intrahepatic Cholangiocarcinoma, Liver Cancer, Liver Metastases
Conditions
Brief summary
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
Interventions
RADIATIONMRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
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.
Sponsors
Stanford University
Viewray Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Overall Survival (OS) | 1 year after SABR | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events | Within 90 days of completing SABR | Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 gastrointestinal adverse events (including fatigue, nausea, diarrhea, or GI pain) attributable to SABR. |
| Rate of Grade ≥ 2 Radiation Pneumonitis | Within 90 days of completing SABR | Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 radiation pneumonitis attributable to SABR. |
| Rate of Grade ≥ 2 Chest Wall Toxicity | Within 90 days of completing SABR | Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 chest wall toxicity attributable to SABR. |
| Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR | 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. |
| Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR | 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. |
| Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR | Up to 1 year post-SABR | Financial toxicity will be assessed using the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire. Scores range from 0 to 44, with higher scores indicating lower financial toxicity (better financial well-being). |
| Rate of Patients With Total Delivery Time > 120 Minutes | Baseline | Percentage of patients with total SABR delivery time exceeding 120 minutes. |
Countries
United States
Contacts
CONTACTEleanor Brown
Outcome results
None listed