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Background Whole brain radiation therapy (WBRT) is the standard therapy for multiple brain metastases. However, WBRT has a poor local tumor control and is associated with a decline in neurocognitive function (NCF). Aim of this trial is to assess the efficacy and safety of a new treatment method, the WBRT with hippocampus avoidance (HA) combined with the simultaneous integrated boost (SIB) on metastases/resection cavities (HA-WBRT+SIB). Methods This is a prospective, randomized, two-arm phase II multicenter trial comparing the impact of HA on NCF after HA-WBRT+SIB versus WBRT+SIB in patients with multiple brain metastases. The study design is double-blinded. One hundred thirty two patients are to be randomized with a 1:1 allocation ratio. Patients between 18 and 80 years old are recruited, with at least 4 brain metastases of solid tumors and at least one, but not exceeding 10 metastases ≥5 mm. Patients must be in good physical condition and have no metastases/resection cavities in or within 7 mm of the hippocampus. Patients with dementia, meningeal disease, cerebral lymphomas, germ cell tumors, or small cell carcinomas are excluded. Previous irradiation and resection of metastases, as well as the number and size of metastases to be boosted have to comply with certain restrictions. Patients are randomized between the two treatment arms: HA-WBRT+SIB and WBRT+SIB. WBRT is to be performed with 30 Gy in 12 daily fractions and the SIB with 51 Gy/42 Gy in 12 daily fractions on 95% of volume for metastases/resection cavities. In the experimental arm, the dose to the hippocampi is restricted to 9 Gy in 98% of the volume and 17Gy in 2% of the volume. NCF testing is scheduled before WBRT, after 3 (primary endpoint), 9, 18 months and yearly thereafter. Clinical and imaging follow-ups are performed 6 and 12 weeks after WBRT, after 3, 9, 18 months and yearly thereafter. Discussion This is a protocol of a randomized phase II trial designed to test a new strategy of WBRT for preventing cognitive decline and increasing tumor control in patients with multiple brain metastases. Trial registration The HIPPORAD trial is registered with the German Clinical Trials Registry ( DRKS00004598 , registered 2 June 2016).

Background Patients with left-sided breast cancer have an increased risk of cardiovascular disease (CVD) after radiotherapy (RT). While the awareness of cardiac toxicity has increased enormously over the last decade, the role of individual baseline cardiac risks has not yet been systematically investigated. Aim of the present study was to evaluate the impact of baseline CVD risks on radiation-induced cardiac toxicity. Methods Two hundred ten patients with left-sided breast cancer treated in the prospective Save-Heart Study using a deep inspiration breath-hold (DIBH) technique were analysed regarding baseline risk factors for CVD. Three frequently used prediction tools (Procam, Framingham and Reynolds score) were applied to evaluate the individual CVD risk profiles. Moreover, 10-year CVD excess absolute risks (EAR) were estimated using the individual mean heart dose (MHD) of treatment plans in free breathing (FB) and DIBH. Results The individual baseline CVD risk factors had a strong impact on the 10-year cumulative CVD risk. The mean baseline risks of the non-diabetic cohort ( n  = 200) ranged from 3.11 to 3.58%, depending on the risk estimation tool. A large number of the non-diabetic patients had a very low 10-year CVD baseline risk of ≤1%; nevertheless, 8–9% of patients reached ≥10% baseline 10-year CVD risk. In contrast, diabetic patients ( n  = 10) had significantly higher baseline CVD risks (range: 11.76–24.23%). The mean 10-year cumulative risk (Framingham score) following RT was 3.73% using the DIBH-technique (MHD:1.42Gy) and 3.94% in FB (MHD:2.33Gy), after adding a 10-year-EAR of + 0.34%(DIBH) and + 0.55%(FB) to the baseline risks, respectively. Smoking status was one of the most important and modifiable baseline risk factors. After DIBH-RT, the 182 non-smoking patients had a mean 10-year cumulative risk of 3.55% (3.20% baseline risk, 0.35% EAR) as compared to 6.07% (5.60% baseline risk, 0.47% EAR) for the 28 smokers. Conclusion In the present study, all CVD prediction tools showed comparable results and could easily be integrated into daily clinical practice. A systematic evaluation and screening helps to identify high-risk patients who may benefit from primary prevention. This could result in an even higher benefit than from heart-sparing irradiation techniques alone.

Purpose The purpose is to show the impact of patient coaching and home practice using the deep inspiration breath hold (DIBH) technique on radiation treatment set-up times and cardiac at-risk doses. Methods The study involved patients who received tangential field radiotherapy using the DIBH technique for treating left breast cancer. Patients were divided into two groups: the first group consisted of those who received coaching from an oncology nurse and were given an instruction sheet at least 1 week before the computed tomography (CT) simulation. The second group consisted of those who were only taught how to hold their breath by the radiation technician on the simulation day and without further education. During treatment, the patients were monitored using the Varian RPM™ respiratory gating system, and 2D kV orthogonal imaging was performed daily. The setup duration of each patient was noted and compared between treatment groups. For each patient, the dose-volume histograms (DVHs) of the heart, LAD (left anterior descending artery), were calculated and compared for both coached DIBH (cDIBH) and non-coached DIBH (ncDIBH). Results Thirty-six coached and 28 non-coached patients were identified. Compared with ncDIBH, coached patients were older (55.5 versus 46.5, p  = 0.003) and had a significantly higher BMI (body mass index) (29.95 versus 26.32 kg/m 2 , p  = 0.006). Nevertheless, in more than half of the treatment fractions, the set-up duration was detected to be statistically longer in the ncDIBH group than in the cDIBH group. Additionally, the LAD max dose was significantly lower in the cDIBH group (36.5 versus 29.5, p  = 0.02). Conclusion Coaching at least 1 week before the simulation with an instruction sheet decreased the set-up duration, and the cardiac LAD max dose should be further decreased by this method.

Background Esophageal carcinoma is the eighth most common cancer in the world. Volumetric‐modulated arc therapy (VMAT) is widely used to treat distal esophageal carcinoma due to high conformality to the target and good sparing of organs at risk (OAR). It is not clear if small‐spot intensity‐modulated proton therapy (IMPT) demonstrates a dosimetric advantage over VMAT. In this study, we compared dosimetric performance of VMAT and small‐spot IMPT for distal esophageal carcinoma in terms of plan quality, plan robustness, and interplay effects. Methods 35 distal esophageal carcinoma patients were retrospectively reviewed; 19 patients received small‐spot IMPT and the remaining 16 of them received VMAT. Both plans were generated by delivering prescription doses to clinical target volumes (CTVs) on phase‐averaged 4D‐CT's. The dose‐volume‐histogram (DVH) band method was used to quantify plan robustness. Software was developed to evaluate interplay effects with randomized starting phases for each field per fraction. DVH indices were compared using Wilcoxon rank‐sum test. For fair comparison, all the treatment plans were normalized to have the same CTVhigh D95% in the nominal scenario relative to the prescription dose. Results In the nominal scenario, small‐spot IMPT delivered statistically significantly lower liver Dmean and V30Gy[RBE], lung Dmean, heart Dmean compared with VMAT. CTVhigh dose homogeneity and protection of other OARs were comparable between the two treatments. In terms of plan robustness, the IMPT and VMAT plans were comparable for kidney V18Gy[RBE], liver V30Gy[RBE], stomach V45Gy[RBE], lung Dmean, V5Gy[RBE], and V20Gy[RBE], cord Dmax and D0.03cm3, liver Dmean, heart V20Gy[RBE], and V30Gy[RBE], but IMPT was significantly worse for CTVhigh D95%, D2cm3, and D5%‐D95%, CTVlow D95%, heart Dmean, and V40Gy[RBE], requiring careful and experienced adjustments during the planning process and robustness considerations. The small‐spot IMPT plans still met the standard clinical requirements after interplay effects were considered. Conclusions Small‐spot IMPT decreases doses to heart, liver, and total lung compared to VMAT as well as achieves clinically acceptable plan robustness. Our study supports the use of small‐spot IMPT for the treatment of distal esophageal carcinoma.

Purpose To minimize radiation exposure to the small bowel (SB) in patients undergoing treatment for gynecological tumors by adopting a comfortable positioning method. Methods and patients All 76 women undergoing Intensity-Modulated Radiation Therapy (IMRT) were included in this study. Patients were immobilized in a supine position using a vacuum bag and thermoplastic cast formation. In the trial group ( n  = 36), patients raised their buttocks and a solid foam pad was placed under the sacral tail before immobilization. The control group ( n  = 40) received treatment in the standard supine position. The SB was delineated from the pubic symphysis to the total iliac bifurcation in computed tomography (CT) scans. Result In the trial group, a significant reduction in SB volume within the pelvic cavity was observed (mean 399.17 ± 158.7 cc) compared to the control group (mean 547.48 ± 166.9 cc), with a p -value less than 0.001. The trial group showed a statistically significant reduction in the absolute volume of irradiated SB at each dose, ranging from the low dose (10 Gy) to the high dose (45 Gy). In the control group, a negative correlation was found between SB and bladder volumes ( R = -0.411, P  = 0.008), whereas in the trial group, this correlation was weaker ( R = -0.286, P  = 0.091), with no significant relationship observed between bladder volume and SB. Conclusion The high buttocks supine position effectively reduces SB radiation exposure without the need for bladder distension. This positioning method holds promise for reducing SB irradiation in various pelvic tumors.

Purpose Results of a prospective, randomized controlled trial at our institute demonstrate an association between the dose to the left hippocampus and neurocognitive decline post‐radiotherapy for patients with glioblastoma. To minimize the dose to the left hippocampus, a left hippocampus sparing model was created using RapidPlan (RP) and multi‐criteria optimization (MCO). Materials and methods For 147 patients with newly diagnosed glioblastoma treated with volumetric modulated arc therapy (VMAT), the left and right hippocampus were delineated. Ninety‐seven of 147 VMAT plans were used to configure a RP model named HCS1. The remaining 50 VMAT plans were used for the model validation. All 97 plans were replanned with the HCS1 and further optimized using MCO (HCS1+MCO). MCO was used to explore the trade‐off between reducing the left hippocampus mean dose and planning objectives for the targets and other organs‐at‐risk (OAR) for HCS1 plans. These plans were used to create a new model called HCS2. MCO and RP model configuration were done within the Eclipse treatment planning system. Results The final HCS2 model decreased the mean dose to the left hippocampus by 26% compared to clinically treated plans without reducing target coverage for 50 validation data. The mean dose to the left hippocampus decreased from 32.65 Gy in clinically treated plans, 30.45 Gy in HCS1‐generated plans, and 24.04 Gy in HCS2‐generated plans. The mean volume receiving 95% of the prescription dose (V95%) of the planning target volume was 99.08% ± 1.39% in clinically treated plans, 99.03% ± 1.37% in HCS1‐generated plans, and 98.80% ± 1.48% in HCS2‐generated plans. Mean dose to 0.1 cc of the brainstem improved from 45.91 Gy in clinically treated plans to 39.29 Gy in HCS2‐generated plans. Conclusions The RP model and MCO helps to decrease left hippocampus mean dose while maintaining the target volume coverage and OAR sparing comparable to clinically treated plans for glioblastoma patients.

BackgroundPublished treatment technique comparisons for postoperative left-sided whole breast irradiation (WBI) with deep-inspiration breath-hold (DIBH) are scarce, small, and inconclusive. In this study, fully automated multi-criterial plan optimization, generating a single high-quality, Pareto-optimal plan per patient and treatment technique, was used to compare for a large patient cohort 1) intensity modulated radiotherapy (IMRT) with two tangential fields and 2) volumetric modulated arc therapy (VMAT) with two small tangential subarcs.Materials and methodsForty-eight randomly selected patients recently treated with DIBH and 16 × 2.66 Gy were included. The optimizer was configured for the clinical planning protocol. Comparisons between IMRT and VMAT included dosimetric plan parameters, estimated excess relative risks (ERR) for toxicities, delivery times, MUs, and deliverability accuracy at a linac.ResultsThe automatically generated IMRT and VMAT plans applied in this study were similar or higher in quality than the manually generated clinical plans. For equal PTVin V95% (98.4 ± 0.9%), VMAT had significant advantages compared to IMRT regarding breast dose homogeneity and doses in heart and ipsilateral lung, at the cost of some minor deteriorations for contralateral breast (few cases with larger deteriorations) and lung. Conformality improved from 1.38 to 1.18 (p < 0.001). With VMAT, ERR for major coronary events and ipsilateral lung tumors were reduced by 3% (range: −1–12%) and 16% (range: −3–38%), respectively. MUs and delivery times were higher for VMAT. There were no statistical differences in γ passing rates.ConclusionFor WBI in conservative therapy of left-sided breast patients treated with DIBH, VMAT with two tangential subarcs was generally dosimetrically superior to IMRT with two tangential static fields. Results need confirmation by robustness analyses.

Background and purpose To explore the feasibility and advantages of the visualized thermosensitive color-changing personalized bolus in post-mastectomy radiotherapy (PMRT). Materials and methods Forty PMRT patients (June 2023–June 2024) were randomized into two groups. Group A (experimental group, 20 patients) underwent two CT scans: A 1 (without compensator) and A 2 (with the visualized thermosensitive color-changing personalized bolus), followed by treatment with the thermosensitive color-changing personalized bolus. Group B (control group, 20 patients) also underwent two CT scans: B 1 (without bolus) and B 2 (with a conventional commercial bolus), followed by treatment with the commercial bolus. Treatment plans were generated for virtual bolus (A 1 -Plan, B 1 -Plan) and real bolus (A 2 -Plan, B 2 -Plan). A 3 -Plan (A 1 -Plan applied to thermosensitive bolus treatment) and B 2 -Plan (B 1 -Plan applied to commercial bolus treatment) were compared to evaluate dosimetric differences in target volumes, organs at risk (OARs), and skin toxicity. Results In Group A, A 1 -Plan and A 2 -Plan showed no significant differences in OAR doses (e.g., ipsilateral lung, heart, contralateral breast, skin D max /D mean ) or target metrics (V 50Gy , D max , homogeneity index (HI), conformity index (CI), monitor units (MU)). A 3 -Plan compared to A 1 -Plan had minor differences in target coverage (94.05% vs. 95.14%), HI (0.148 vs. 0.147), and CI (0.83 vs. 0.84). In Group B, B 2 -Plan had significantly reduced target coverage (89.9% vs. 95%), homogeneity (0.153 vs. 0.136), and conformity (0.817 vs. 0.810) compared to B 1 -Plan, attributed to air gaps from the commercial bolus. The thermosensitive color-changing personalized bolus had better skin adherence, significantly reduced air cavity volumes (3833 mm³ vs. 21498 mm³), and maintained equivalent dosimetric performance to virtual boluses. Skin toxicity was Grade I in all patients without differences between groups. Conclusions The visualized thermosensitive color-changing personalized bolus demonstrated superior skin adherence, smaller air gaps, and better positional reproducibility compared to commercial boluses. Its dosimetric performance was consistent with virtual bolus plans, ensuring target coverage and OAR protection without increased skin toxicity. These findings support its clinical application in PMRT.

Biocompatible gold nanoparticles designed to absorb light at wave-lengths of high tissue transparency have been of particular interest for biomedical applications. The ability of such nanoparticles to convert absorbed near-infrared light to heat and induce highly localized hyperthermia has been shown to be highly effective for photothermal cancer therapy, resulting in cell death and tumor remission in a multitude of preclinical animal models. Here we report the initial results of a clinical trial in which laser-excited gold-silica nanoshells (GSNs) were used in combination with magnetic resonance–ultrasound fusion imaging to focally ablate low-intermediate-grade tumors within the prostate. The overall goal is to provide highly localized regional control of prostate cancer that also results in greatly reduced patient morbidity and improved functional outcomes. This pilot device study reports feasibility and safety data from 16 cases of patients diagnosed with low- or intermediate-risk localized prostate cancer. After GSN infusion and high-precision laser ablation, patients underwent multiparametric MRI of the prostate at 48 to 72 h, followed by postprocedure mpMRI/ultrasound targeted fusion biopsies at 3 and 12 mo, as well as a standard 12-core systematic biopsy at 12 mo. GSN-mediated focal laser ablation was successfully achieved in 94% (15/16) of patients, with no significant difference in International Prostate Symptom Score or Sexual Health Inventory for Men observed after treatment. This treatment protocol appears to be feasible and safe in men with low- or intermediate-risk localized prostate cancer without serious complications or deleterious changes in genitourinary function.

Background A dummy run was conducted to ensure the quality of intensity-modulated radiotherapy (IMRT) before registration in a randomized phase III study of elderly patients with newly diagnosed glioblastoma by the Japan Clinical Oncology Group 1910 (JCOG1910). Methods All 41 institutions enrolled in this study were required to report outlining that included gross tumor volume (GTV), clinical target volume (CTV), planning target volume (PTV), and treatment planning for one benchmark case. First, deviations in outlining were evaluated using the Dice similarity coefficient (DSC) and mean distance agreement (MDA), compared to reference targets delineated by the research secretariat. Second, the participating institutions were required to create treatment plans for arms A (40.05 Gy in 15 fractions) and B (25 Gy in 5 fractions) using IMRT techniques. The quality of the outlining and dose-volume criteria for each target and organs at risk were evaluated. Results Six institutions failed to adhere to the protocol and required revision due to insufficient GTV outlining, not considering anatomical barriers for CTV, and modifying PTV against protocols. Compared to the reference outlining, the means and standard deviations of DSC and MDA were 0.37 ± 0.19 and 9.41 ± 3.99 mm for GTV; 0.80 ± 0.08 and 4.31 ± 1.85 mm for CTV; and 0.83 ± 0.05 and 4.23 ± 1.45 mm for PTV, respectively. Regarding dose-volume criteria, 40 of the 41 institutions met the per-protocol limits; only one was within the acceptable limits. Conclusions Several institutions demonstrated deviations in outlining that necessitated revisions. Thus, appropriate feedback and periodic sharing of information with participating institutions is necessary in the upcoming prospective JCOG1910 study.