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Background A recent randomized phase II trial evaluated stereotactic ablative radiotherapy (SABR) in a group of patients with a small burden of oligometastatic disease (mostly with 1–3 metastatic lesions), and found that SABR was associated with a significant improvement in progression-free survival and a trend to an overall survival benefit, supporting progression to phase III randomized trials. Methods Two hundred and ninety-seven patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care [SOC] palliative-intent treatments), and the SABR arm (consisting of SOC treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (prostate, breast, or renal vs. all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 vs. > 2 years). The primary endpoint is overall survival, and secondary endpoints include progression-free survival, cost effectiveness, time to development of new metastatic lesions, quality of life (QoL), and toxicity. Translational endpoints include assessment of circulating tumor cells, cell-free DNA, and tumor tissue as prognostic and predictive markers, including assessment of immunological predictors of response and long-term survival. Discussion This study will provide an assessment of the impact of SABR on survival, QoL, and cost effectiveness to determine if long-term survival can be achieved for selected patients with 1–3 oligometastatic lesions. Trial registration Clinicaltrials.gov identifier: NCT03862911 . Date of registration: March 5, 2019,

Background Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience. Methods This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival. Discussion This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone. Trial registration Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

Background Oligometastases refer to a state of disease where cancer has spread beyond the primary site, but is not yet widely metastatic, often defined as 1–3 or 1–5 metastases in number. Stereotactic ablative radiotherapy (SABR) is an emerging radiotherapy technique to treat oligometastases that require further prospective population-based toxicity estimates. Methods This is a non-randomized phase II trial where all participants will receive experimental SABR treatment to all sites of newly diagnosed or progressing oligometastatic disease. We will accrue 200 patients to assess toxicity associated with this experimental treatment. The study was powered to give a 95% confidence on the risk of late grade 4 toxicity, anticipating a < 5% rate of grade 4 toxicity. Discussion SABR treatment of oligometastases is occurring off-trial at a high rate, without sufficient evidence of its efficacy or toxicity. This trial will provide necessary toxicity data in a population-based cohort, using standardized doses and organ at risk constraints, while we await data on efficacy from randomized phase III trials. Trial Registration Registered through clinicaltrials.gov NCT02933242 on October 14, 2016 prospectively before patient accrual.

Background Bone metastases in the lower spine and pelvis are effectively palliated with radiotherapy (RT), though this can come with side effects such as radiation induced nausea and vomiting (RINV). We hypothesize that high rates of RINV occur in part because of the widespread use of inexpensive simple unplanned palliative radiotherapy (SUPR), over more complex and resource intensive 3D conformal RT, such as volumetric modulated arc therapy (VMAT). Methods This is a randomized, multi-centre phase III trial of SUPR versus VMAT. We will accrue 250 patients to assess the difference in patient-reported RINV. This study is powered to detect a difference in quality of life between patients treated with VMAT vs. SUPR. Discussion This trial will determine if VMAT reduces early toxicity compared to SUPR and may provide justification for this more resource-intensive and costly form of RT. Trial registration Clinicaltrials.gov identifier: NCT03694015 . Date of registration: October 3, 2018.

Stereotactic ablative radiotherapy is being increasingly adopted in the treatment of lung tumors. The use of proton beam therapy can further reduce dose to normal structures. However, uncertainty exists in proton-based treatment plans, including range uncertainties, large sensitivity to position uncertainty, and calculation of dose deposition in heterogeneous areas. This study investigated the feasibility of proton transmission beams, i.e. without the Bragg peak, to treat lung tumors with stereotactic ablative radiotherapy. We compared three representative treatment plans using proton transmission beams versus conformal static-gantry photon beams. It was found that proton treatment plans using transmission beams passing through the patient were feasible and demonstrated lower dose to normal structures and markedly reduced treatment times than photon plans. This is the first study to demonstrate the feasibility of proton-based stereotactic ablative radiotherapy planning for lung tumors using proton transmission beams alone. Further research using this novel approach for proton-based planning is warranted.

Purpose To evaluate the feasibility of an open‐source, semi‐automated, and reproducible vertex placement tool to improve the efficiency of lattice radiotherapy (LRT) planning. We used polymer gel dosimetry with a Cone Beam CT (CBCT) readout to commission this LRT technique. Material and methods We generated a volumetric modulated arc therapy (VMAT)‐based LRT plan on a 2 L NIPAM polymer gel dosimeter using our Eclipse Acuros version 15.6 AcurosXB beam model, and also recalculated the plan with a pre‐clinical Acuros v18.0 dose calculation algorithm with the enhanced leaf modelling (ELM). With the assistance of the MAAS‐SFRThelper software, a lattice vertex diameter of 1.5 cm and center‐to‐center spacing of 3 cm were used to place the spheres in a hexagonal, closed packed structure. The verification plan included four gantry arcs with 15°, 345°, 75°, 105° collimator angles. The spheres were prescribed 20 Gy to 50% of their combined volume. The 6 MV Flattening Filter Free beam energy was used to deliver the verification plan. The dosimetric accuracy of the LRT delivery was evaluated with 1D dose profiles, 2D isodose maps, and a 3D global gamma analysis. Results Qualitative comparisons between the 1D dose profiles of the Eclipse plan and measured gel showed good consistency at the prescription dose mark. The average diameter measured 13.3 ± 0.2 mm (gel for v15.6), 12.6 mm (v15.6 plan), 13.1 ± 0.2 mm (gel for v18.0), and 12.3 mm (v18.0 plan). 3D gamma analysis showed that all gamma pass percent were > 95% except at 1% and 2% at the 1 mm distance to agreement criteria. Conclusion This study presents a novel application of gel dosimetry in verifying the dosimetric accuracy of LRT, achieving excellent 3D gamma results. The treatment planning was facilitated by publicly available software that automatically placed the vertices for consistency and efficiency.

A 74-year-old woman with pathologic T4a N1 M0 adenocarcinoma of the cecum, initially treated with right hemicolectomy, developed rising serum carcinoembryonic antigen levels while receiving adjuvant chemotherapy. Re-staging investigations demonstrated two soft tissue metastases in the right abdomen comprised of a retrocolic lesion immediately posterior to the colon and a retroperitoneal lesion with no other sites of metastases. The patient was treated with stereotactic ablative radiotherapy (SABR) to a dose of 40 Gy in five daily fractions to both pericolonic soft tissue metastases simultaneously. A standard volumetric modulated arc therapy (VMAT) plan had suboptimal dose coverage of the retrocolic metastasis adjacent to the colon, so cone-beam computed tomography (CBCT)-guided online adaptive radiotherapy (ART) was employed to maximize radiation dose to the tumors due to the radioresistant histology. An intensity-modulated radiotherapy (IMRT) plan was created using artificial intelligence tools integrated with the treatment unit. Median contouring and plan creation for each fraction was 21.5 minutes (range 14.9-28.1). For the retrocolic metastasis, compared to the standard VMAT plan, the CBCT-guided online ART plan improved coverage of the gross target volume by the prescription dose from 80.0% to 99.7%. SABR to pericolonic soft tissue metastases was feasible using CBCT-guided online ART and can significantly improve target volume coverage when targets are adjacent to mobile normal organs, which may be particularly important for radioresistant histologies for local control.

A 32-year-old man with medulloblastoma was initially treated with subtotal resection and craniospinal irradiation. He developed recurrent metastatic disease three years later with extensive bone-only metastases. Biopsy of the bone lesions confirmed metastatic medulloblastoma and restaging investigations demonstrated a superscan with no evidence of recurrence in the craniospinal axis. Extraneural metastatic medulloblastoma is rare, and the presentation with diffuse bone-only metastases with a superscan on imaging is unique. The patient had diffusely painful bone metastases requiring multiple hospitalizations for poor pain control. He declined chemotherapy and was treated with radium-223, an alpha particle emitting radionuclide therapy typically used in metastatic castrate-resistant prostate cancer. The patient received three out of a planned six cycles of radium-223 before it was discontinued due to myelosuppression requiring multiple blood transfusions, and restaging demonstrated local recurrence in the posterior fossa. This is the first report to our knowledge describing the use of radium-223 in a patient with extraneural bone-only metastatic medulloblastoma. Further research into the effect of radium-223 in patients with diffuse bone-only metastases from non-prostate cancer primary tumors is warranted.

Purpose This study evaluates the dosimetric and geometric precision of a virtual cone technique using CBCT‐based polymer gel dosimetry, enabling radiation delivery, and imaging readout within an identical spatial coordinate system. Methods We created a C# script for a virtual cone technique that generates a treatment plan with 10 gantry arcs at 0°, 36°, 72°, 288°, and 324° couch angles, with 2 arcs per couch angle using 45° and 135° collimator angles. Two verification plans using Eclipse v15.6 (AcurosXB) were created with 20 Gy at the maximum dose for: (1) a cylindrical gel, with an additional calibration region; (2) a 3D printed anthropomorphic skull phantom with a gel insert. The 50% isodose (10 Gy) width through the central axis of the axial and sagittal planes (SPs) were measured for the gel experiment. The distance between the centers‐of‐masses of the 10 Gy isodose region of the plan and the gel (skull phantom) were calculated for an end‐to‐end spatial accuracy test. Results The maximum point dose measured with gel was within 1% of the plan, though the gel measured 50% isodose widths of 5.56± $\\; \\pm \\;$ 0.02 mm, 5.65 ± $ \\pm \\;$ 0.04 mm, 4.23 ± $ \\pm \\;$ 0.01 mm for axial (anterior–posterior), axial (left–right), sagittal (superior–inferior) respectively, which were slightly narrower than Eclipse (1.29 mm maximum difference in the SP due to CBCT slice thickness). The center‐of‐mass distance was 0.66 mm for the gel experiment, and 0.94 mm for complete end‐to‐end testing with the anthropomorphic phantom, including CBCT setup (kV‐MV isocenter uncertainty). Conclusion The 50% isodose width of the gel measurement was 5.15 mm (mean), which was tighter than our Eclipse v15.6 beam model. The end‐to‐end spatial accuracy test, only achievable with gel dosimetry using CBCT readout, resulted in sub‐millimeter accuracy. This study demonstrates the value of gel dosimetry in verifying the dosimetric and spatial accuracy of this high precision, stereotactic technique.

Linac-based stereotactic radiosurgery (SRS) with planning target volume (PTV) margins <1 mm has become increasingly common in recent years. Optical surface imaging for surface-guided radiation therapy (SGRT) is often used for intra-fraction motion monitoring during these treatments to facilitate the use of a smaller PTV margin by providing real-time quantitative patient positioning information. However, rotating the couch introduces errors to SGRT-reported translations and rotations that can be problematic for SRS treatments with non-coplanar arcs and very small PTV margins. This work presents a novel approach for decreasing the magnitude of these errors by performing a pre-treatment dry run and capturing reference surfaces with the SGRT system at each couch angle included in the treatment plan. Time from cone beam computed tomography (CBCT) to treatment initiation and total treatment session time were reviewed for 30 single-fraction brain SRS cases treated using this technique to determine the effect of including the dry run on treatment session times. Out of the 30 cases treated between April 2023 and January 2024, 23 treatments required only a single CBCT prior to treatment, with no additional mid-treatment imaging required to verify patient positioning after motion. The median time between CBCT and treatment initiation was 7.98 minutes (interquartile range (IQR) = 7.28 to 8.93 minutes). The median time from CBCT to treatment completion was 15.43 minutes (IQR = 13.67 to 21.97 minutes). In the six patients that required one additional CBCT, the treatment session times ranged from 24.32 to 32.83 minutes. There was one patient who required three mid-treatment CBCTs, and the treatment session time was 67.87 minutes. Incorporating the pre-treatment dry run with the acquisition of reference surfaces at each treatment angle decreased errors in SGRT-reported translations and rotations associated with couch rotation without significantly increasing treatment session times.