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| Name | Class |
|---|---|
| Viewray Inc. | INDUSTRY |
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Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR) | Experimental | Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after SABR |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 90 days of completing SABR |
| Rate of Grade ≥ 2 Radiation Pneumonitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleanor Brown | Contact | 650-497-8966 | eleanor9@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 radiation pneumonitis attributable to SABR. |
| 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. | 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. | 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. | Up to 1 year post-SABR |
| Change from Baseline in COST-FACIT Total Score 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). | Up to 1 year post-SABR |
| Rate of Patients With Total Delivery Time > 120 Minutes | Percentage of patients with total SABR delivery time exceeding 120 minutes. | Baseline |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |