Biologically 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.

Introduction: 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 (BED ₁₀ , α/β=10) of 60-70 Gy with those of BED ₁₀ >70 Gy.
Methods and Analysis: This study is a single-centre, phase II trial. Patients with LAPC are randomly allocated to receive SBRT with BED ₁₀ 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.
Ethics and Dissemination: 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.
Trial Registration Numbers: NCT04603586.
Competing Interests: Competing interests: None declared.
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