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Biologically effective dose (BED) escalation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma patients (?5?cm) with CyberKnife: protocol of study.

ABSTRACT: BACKGROUND:There is a lack of data on the biologically effective dose and the efficacy of stereotactic body radiotherapy in hepatocellular carcinoma patients, and this study was conducted to explore the relation between BED and efficacy. METHODS:This study is designed as a mono-center study. The participants are randomized into three group, and received the following recommended schedule: 49Gy/7f, 54Gy/6f and 55Gy/5f with BED10 in correspondence to 83.3Gy, 102.6Gy and 115.5Gy. The primary outcome measures are to calculate local control rates (LC), overall survival rates (OS) and progression-free survival rates (PFS). The secondary outcome measures are to observe radiation-induced liver injury (RILD) rates, Child-Pugh score and indocyanine green retention rate at 15?min (ICG-R15) value before and after CK-SBRT. Moreover, gastrointestinal toxicities are also observed. DISCUSSION:There is no uniform standard for CK-SBRT dose schedule of hepatocellular carcinoma. We propose to conduct a study determining the optimal CK-SBRT schedule of hepatocellular carcinoma patients (?5?cm). The trial protocol has been approved by the Institutional Review Board of 302 Hospital of PLA (People's Liberation Army). The Ethics number is 2017111D. TRAIL REGISTRATION:Clinical trails number: NCT03295500. Date of registration: November, 2017.

SUBMITTER: Sun J

PROVIDER: S-EPMC6986016 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Biologically effective dose (BED) escalation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma patients (≤5 cm) with CyberKnife: protocol of study.

Sun Jing J Zhang Aimin A Li Wengang W Wang Quan Q Li Dong D Zhang Dan D Duan Xuezhang X

Radiation oncology (London, England) 20200128 1

<h4>Background</h4>There is a lack of data on the biologically effective dose and the efficacy of stereotactic body radiotherapy in hepatocellular carcinoma patients, and this study was conducted to explore the relation between BED and efficacy.<h4>Methods</h4>This study is designed as a mono-center study. The participants are randomized into three group, and received the following recommended schedule: 49Gy/7f, 54Gy/6f and 55Gy/5f with BED<sub>10</sub> in correspondence to 83.3Gy, 102.6Gy and 1 ...[more]

PMID: 31992327

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Project description:Stereotactic body radiotherapy (SBRT) is a novel noninvasive treatment for hepatocellular carcinoma. SBRT can achieve effective local control, but it requires a relatively high input of resources; this systematic review was performed to assess the cost effectiveness of SBRT in the treatment of hepatocellular carcinoma to provide a basis for government pricing and medical insurance decision-making. The PubMed, EMBASE, Cochrane Library, CNKI, Wanfang and SinoMed databases were searched to collect economic evaluations of SBRT for the treatment of hepatocellular carcinoma from the date of database inception through December 31, 2018. Two reviewers independently screened the studies, extracted the data and performed a descriptive analysis of the basic characteristics, methods of economic evaluation and main results, as well as the quality and heterogeneity of the reports. A total of 5 studies were included. Among them, the level of heterogeneity was relatively acceptable, with a median score of 90%. Four studies were cost-utility analyses (CUAs), and 1 was a cost-effectiveness analysis (CEA). The incremental cost effectiveness ratio (ICER) for sorafenib compared to SBRT was US $114,795 per quality-adjusted life year gained (cost/QALY) in patients with advanced hepatocellular carcinoma. The ICER for proton beam therapy compared to SBRT was US $6465 in patients with inoperable advanced hepatocellular carcinoma. The ICER for SBRT compared to RFA was US $164,660 for patients with unresectable colorectal cancer (CRC) with liver metastases and US $56,301 for patients with early-stage hepatocellular carcinoma. For patients with inoperable localized hepatocellular carcinoma, compared with RFA-SBRT therapy, the ICERs for SBRT-SBRT and SBRT-RFA were US $558,679 and US $2197,000, respectively; RFA-RFA was dominated. In conclusion, there is limited evidence suggesting that SBRT could be cost-effective for highly specific subpopulations of HCC patients, and further economic evaluations based on randomized controlled trials (RCTs) or cohort studies are needed.

Project description:PurposeTo assess the potential dosimetric benefits associated with the CyberKnife (CK) tumor tracking capability, wherein an extra margin for respiratory tumor motion is not required, when compared to respiratory-gated volumetric-modulated arc therapy (VMAT) for hepatocellular carcinoma (HCC).MethodsTwenty-nine HCC patients previously treated with double-arc VMAT were enrolled. In each VMAT plan, the individual internal target volume (ITV) margin around the tumor was determined by measuring its motion over 30-70% of respiratory phases using four-dimensional computed tomography, followed by a 5-mm isotropic margin for the planning target volume (PTV). For each VMAT plan, two CK plans were generated using the original (CKoriginal, ITV included) and modified PTVs (CKmodified, ITV excluded) for comparison. In each case, the CKoriginal and CKmodified plans were compared to the original VMAT plan in terms of the dosimetric parameters including the conformity index (CI), PTV coverage (CO), organs at risk (OAR) doses, and normal liver tissue sparing.ResultsThe original PTVs with median 24 cc (range, 9-65 cc) were significantly reduced to median 12 cc (range, 5-41 cc) in the CKmodified plans. Statistically significant differences in plan qualities were observed between the VMAT and the CK plans: mean CI, 1.05 in VMAT vs. 1.17 in both CK plans (p < 0.001); and mean CO, 93.0% in VMAT vs. 96.6% in CKoriginal and 96.9% in CKmodified (p < 0.001). The average volume of normal liver tissue receiving > 15 Gy was significantly decreased in the CKmodified plan, as compared to that in the VMAT and CKoriginal plans, by 1.75- and 1.61-fold, respectively.ConclusionsThe tumor tracking capability of the CK system can significantly decrease the volume of normal liver tissue receiving > 15 Gy, while maintaining high precision in target localization, conformity, tumor coverage, and dose sparing of the OAR. Therefore, it can be a valuable SBRT option, particularly for HCC patients with poor liver function.

Dataset Information

Biologically effective dose (BED) escalation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma patients (?5?cm) with CyberKnife: protocol of study.

Publications

Biologically effective dose (BED) escalation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma patients (≤5 cm) with CyberKnife: protocol of study.

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