An International Consensus on the Design of Prospective Clinical–Translational Trials in Spatially Fractionated Radiation Therapy

Abstract

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An International Consensus on the Design of Prospective Clinical–Translational Trials in Spatially Fractionated Radiation Therapy for Advanced Gynecologic Cancer

“…The GLMF Radiotherapy Working Groups had been established subsequent to a 2018 National Cancer Institute’s Radiation Research Program/RSS Workshop, and their goal is to advance the biological, technical/physical, and clinical understanding of these novel radiation approaches [ 26 , 27 ]. The consensus reported here is part of the GLMF Radiotherapy Working Groups project of developing design consensus for clinical SFRT trials in primary (non-metastatic) head and neck [ 28 ], lung, gynecologic cancer, and sarcoma [ 28 ].…”

“…The process of developing a clinical trial design consensus is summarized in Table 1 and has been previously described in detail [ 28 ]. In brief, the consensus followed a formal 12-step process as shown in the table.…”

“…Anonymous electronic rank voting (on a ranking scale of 1–9) was carried out by the experts. The voting process, vote analysis and statistical model (step 4) that was developed to interpret the rank voting data, have been described previously [ 28 ] and is presented in Table 1 .…”

“… Note: cERT = conventional external radiation therapy. Table adapted and reprinted with permission from Mayr et al [ 28 ]. …”

“…To address challenges towards the development of prospective multi-institutional SFRT trials, the consensus development for clinical trial design of SFRT in primary malignancies has been a major effort of the Radiosurgery Society (RSS) GRID , Lattice , Microbeam and Flash (GLMF) Radiotherapy Working Groups [ 26 , 27 ]. In this initiative, major disease sites have been [ 28 ] and are currently evaluated for trial feasibility and clinical trial design consensus. Here, we report the clinical trial design consensus for gynecologic cancers.…”