Trial Summary
What is the purpose of this trial?This trial will provide the maximum tolerated dose for radiation therapy for liver tumors and describe the toxicity profile using the vGRID therapy technique. Based on trials using this type of radiation in other cancers demonstrating low toxicity rates even with very high radiation doses and high efficacy, it is likely that vGRID therapy in this trial will be well tolerated and allow dose escalation beyond currently common doses for liver tumors.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using immunosuppressive drugs like corticosteroids or TNF-alpha blockers, you may not be eligible to participate. It's best to discuss your current medications with the trial team.
What data supports the idea that SBRT for Liver Cancer is an effective treatment?
The available research shows that SBRT is an effective treatment for liver cancer. One study highlights that SBRT can effectively target liver tumors while minimizing damage to nearby healthy organs, even when these organs move between treatment sessions. Another study provides guidelines to ensure SBRT is used safely and effectively for liver tumors. These findings suggest that SBRT is a promising option for treating liver cancer, offering precise targeting of tumors with careful planning and monitoring.
12345What safety data is available for SBRT in liver cancer treatment?
Several studies provide safety data for SBRT in liver cancer treatment. A prospective registry study on MR-guided radiotherapy (MRgRT) for primary liver tumors reports on acute and late toxicities, indicating safe outcomes. Another study on marker-less MR-guided SBRT for liver metastases discusses feasibility, workflow, and toxicity, suggesting patient acceptance and safety. The DEGRO Working Group provides guidelines for safe SBRT of liver tumors. A study on robotic SBRT for hepatocellular carcinoma (HCC) investigates safety factors. Additionally, a retrospective study on image-guided liver SBRT using VMAT reports no grade 3 toxicity, with one case of grade 4 gastric ulcer, indicating overall safety and effectiveness in heavily pre-treated patients.
46789Is the treatment vGRID a promising treatment for liver cancer?
Yes, vGRID, a type of stereotactic body radiation therapy (SBRT), is promising for liver cancer. It offers precise targeting of liver tumors, which can lead to high local control rates and improved patient outcomes. This treatment is also efficient and can be used for patients with multiple liver metastases, potentially improving their quality of life.
34101112Eligibility Criteria
This trial is for adults with unresectable or metastatic hepatocellular carcinoma (liver cancer) who have adequate blood counts, liver and kidney function, and are not pregnant. They must agree to use contraception and cannot be eligible for a transplant or have severe active comorbidities like heart failure, uncontrolled bleeding, or infections.Inclusion Criteria
I, or my legal representative, can understand the study and agree to sign the consent form.
I agree not to donate sperm during and for 12 months after the study.
I am 18 years old or older.
+9 more
Exclusion Criteria
My liver cancer is operable or suitable for a transplant.
Severe active co-morbidities
I will not donate blood during or after the study.
+9 more
Participant Groups
The trial is testing the maximum tolerated dose of Stereotactic Body Radiation Treatment (SBRT) using vGRID therapy technique on liver tumors. It aims to find out how much radiation can be given safely while monitoring the side effects.
1Treatment groups
Experimental Treatment
Group I: Single fraction SBRT 27 GyExperimental Treatment1 Intervention
vGRID SBRT 3+3 dose escalation, single fraction, one day cycle length
vGRID is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as vGRID SBRT for:
- Unresectable or metastatic hepatocellular carcinoma (HCC)
🇪🇺 Approved in European Union as vGRID SBRT for:
- Unresectable or metastatic hepatocellular carcinoma (HCC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Kansas Medical CenterKansas City, KS
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Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
VarianCollaborator
Varian Medical SystemsIndustry Sponsor
References
Adaptive liver stereotactic body radiation therapy: automated daily plan reoptimization prevents dose delivery degradation caused by anatomy deformations. [2018]To investigate how dose distributions for liver stereotactic body radiation therapy (SBRT) can be improved by using automated, daily plan reoptimization to account for anatomy deformations, compared with setup corrections only.
The Dosimetric Impact of Interfractional Organ-at-Risk Movement During Liver Stereotactic Body Radiation Therapy. [2020]Stereotactic body radiation therapy (SBRT) is an effective therapy for treating liver malignancies. However, little is known about interfractional dose variations to adjacent organs at risk (OARs). We examine the effects of interfractional organ movement and setup variation on dose delivered to OARs in patients receiving liver SBRT.
Stereotactic radiotherapy in the liver hilum. Basis for future studies. [2021]A basis for future trials with stereotactic body radiotherapy (SBRT) for tumors of the liver hilum should be established. Thus, dosage concepts, planning processes, and dose constraints as well as technical innovations are summarized in this contribution.
Stereotactic body radiotherapy for liver tumors: principles and practical guidelines of the DEGRO Working Group on Stereotactic Radiotherapy. [2022]This report of the Working Group on Stereotactic Radiotherapy of the German Society of Radiation Oncology (DEGRO) aims to provide a practical guideline for safe and effective stereotactic body radiotherapy (SBRT) of liver tumors.
Evaluation of reproducibility of tumor repositioning during multiple breathing cycles for liver stereotactic body radiotherapy treatment. [2022]To evaluate the tumor repositioning during gated volumetric modulated arc therapy (VMAT) for liver stereotactic body radiotherapy(SBRT) treatment using implanted fiducial markers and intrafraction kilovoltage (kV) images acquired during dose delivery.
A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023]Stereotactic body radiation therapy (SBRT) has demonstrated safe and effective results for primary liver tumors. Magnetic Resonance guided Radiotherapy (MRgRT) is an innovative radiotherapy modality for abdominal tumors. The aim of this study is to report on acute and late toxicities and initial oncological results for primary liver tumors treated with MRgRT.
Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. [2022]Stereotactic body radiotherapy (SBRT) is an established ablative treatment for liver tumors with excellent local control rates. Magnetic resonance imaging guided radiotherapy (MRgRT) provides superior soft tissue contrast and may therefore facilitate a marker-less liver SBRT workflow. The goal of the present study was to investigate feasibility, workflow parameters, toxicity and patient acceptance of MRgSBRT on a 1.5 T MR-Linac.
Analysis of the factors affecting the safety of robotic stereotactic body radiation therapy for hepatocellular carcinoma patients. [2022]The objective of this study was to investigate the safety of robotic stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC) patients and its related factors.
Image-Guided Liver Stereotactic Body Radiotherapy Using VMAT and Real-Time Adaptive Tumor Gating: Evaluation of the Efficacy and Toxicity for Hepatocellular Carcinoma. [2021]Liver SBRT is a therapeutic option for the treatment of HCC in patients not eligible for other local therapies. We retrospectively report the outcomes of a cohort of consecutive patients treated with SBRT for HCC at the Montpellier Cancer Institute. Between March 2013 and December 2018, 66 patients were treated with image-guided liver SBRT using VMAT and real-time adaptive tumor gating in our institute. The main endpoints considered in this study were local control, disease-free survival, overall survival, and toxicity. The median follow-up was 16.8 months. About 66.7% had prior liver treatment. Most patients received 50 Gy in five fractions of 10 Gy. No patient had local recurrence. Overall survival and disease-free survival were, respectively, 83.9% and 46.7% at one year. In multivariate analysis, the diameter of the lesions was a significant prognostic factor associated with disease-free survival (HR = 2.57 (1.19-5.53) p = 0.02). Regarding overall survival, the volume of PTV was associated with lower overall survival (HR = 2.84 (1.14-7.08) p = 0.025). No grade 3 toxicity was observed. One patient developed a grade 4 gastric ulcer, despite the dose constraints being respected. Image-guided liver SBRT with VMAT is an effective and safe treatment in patients with inoperable HCC, even in heavily pre-treated patients. Further prospective evaluation will help to clarify the role of SBRT in the management of HCC patients.
Local control and patient reported outcomes after online MR guided stereotactic body radiotherapy of liver metastases. [2023]Stereotactic body radiotherapy (SBRT) is used to treat liver metastases with the intention of ablation. High local control rates were shown. Magnetic resonance imaging guided radiotherapy (MRgRT) provides the opportunity of a marker-less liver SBRT treatment due to the high soft tissue contrast. We report herein on one of the largest cohorts of patients treated with online MRgRT of liver metastases focusing on oncological outcome, toxicity, patient reported outcome measures (PROMs), quality of life.
Feasibility and dosimetric evaluation of single- and multi-isocentre stereotactic body radiation therapy for multiple liver metastases. [2023]Single-isocentre volumetric-modulated arc therapy (VMAT) stereotactic body radiation therapy (SBRT) improves treatment efficiency and patient compliance for patients with multiple liver metastases (MLM). However, the potential increase in dose spillage to normal liver tissue using a single-isocentre technique has not yet been studied. We comprehensively evaluated the quality of single- and multi-isocentre VMAT-SBRT for MLM and propose a RapidPlan-based automatic planning (AP) approach for MLM SBRT.
Stereotactic body radiation therapy (SBRT) for definitive treatment and as a bridge to liver transplantation in early stage inoperable Hepatocellular carcinoma. [2022]Stereotactic body radiotherapy (SBRT) is an emerging modality for definitive treatment of Hepatocellular carcinoma (HCC).