biostudies-literatureUnknown12(8)Ye Y<h4>Introduction</h4>There is a paucity of studies about whether dose escalation of stereotactic body radiation therapy (SBRT) prolongs survival compared with de-escalation for patients with locally advanced pancreatic cancer (LAPC). Therefore, the aim of the study is to compare the survival benefits of biologically effective dose (BED₁₀, α/β=10) of 60-70 Gy with those of BED₁₀ >70 Gy.<h4>Methods and analysis</h4>This study is a single-centre, phase II trial. Patients with LAPC are randomly allocated to receive SBRT with BED₁₀ of 60-70 Gy or >70 Gy in 5-6 fractions combined with gemcitabine plus albumin-bound paclitaxel. The primary outcome is progression-free survival. The secondary outcomes are adverse events, local control and overall survival.<h4>Ethics and dissemination</h4>The trial protocol has been approved by the Ethics committee of Shanghai Changhai Hospital. The ethics number is CHEC2020-100. Study results will be disseminated through peer-reviewed journals and released in related medical conferences.<h4>Trial registration numbers</h4>NCT04603586.BMJ opene049382https://www.ebi.ac.uk/biostudies/studies/S-EPMC9438046biostudies-literatureBiologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial.PMC9438046Jiang LCao YZhang HZhu XYe YZhao XfalseBiologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial.<h4>Introduction</h4>There is a paucity of studies about whether dose escalation of stereotactic body radiation therapy (SBRT) prolongs survival compared with de-escalation for patients with locally advanced pancreatic cancer (LAPC). Therefore, the aim of the study is to compare the survival benefits of biologically effective dose (BED₁₀, α/β=10) of 60-70 Gy with those of BED₁₀ >70 Gy.<h4>Methods and analysis</h4>This study is a single-centre, phase II trial. Patients with LAPC are randomly allocated to receive SBRT with BED₁₀ of 60-70 Gy or >70 Gy in 5-6 fractions combined with gemcitabine plus albumin-bound paclitaxel. The primary outcome is progression-free survival. The secondary outcomes are adverse events, local control and overall survival.<h4>Ethics and dissemination</h4>The trial protocol has been approved by the Ethics committee of Shanghai Changhai Hospital. The ethics number is CHEC2020-100. Study results will be disseminated through peer-reviewed journals and released in related medical conferences.<h4>Trial registration numbers</h4>NCT04603586.2022-01-01T00:00:00Z2022 Aug2024-11-15T22:46:21.25Z2024-11-15T22:46:21.25ZS-EPMC94380463603816410.1136/bmjopen-2021-049382