A Multicenter Phase II Study Evaluating the Efficacy of Single-Fraction 8 Gy Radiotherapy for Bleeding Gastrointestinal Malignancies: STABLE Study Protocol (Preprint)

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BACKGROUND Bleeding is a common complication of advanced gastrointestinal malignancies. Although radiotherapy is an effective hemostatic treatment, dose-fractionation remains unclear. Single-fraction 8 Gy radiotherapy has been demonstrated in palliative irradiation for conditions such as bone and liver metastases; however, its effectiveness in hemostatic radiotherapy remains uncertain. OBJECTIVE This study aims to prospectively evaluate the efficacy and safety of single-fraction 8 Gy radiotherapy for bleeding gastrointestinal malignancies. METHODS This is a prospective, multicenter, single-arm, open-label phase II trial evaluating single-fraction 8 Gy radiotherapy for bleeding gastrointestinal malignancies. A total of 47 patients will be enrolled from 12 institutions in Japan. The primary endpoint is the hemostasis rate at 4 weeks after radiotherapy in the intention-to-treat population. Secondary endpoints include hemostasis rates at other time points, changes in hemoglobin levels, transfusion requirements, incidence of rebleeding, rebleeding-free interval, salvage treatment use, overall survival, antiemetic use, patient-reported toxicity, and health-related quality of life. RESULTS The study protocol was approved by the Hiroshima University Hospital Institutional Review Board in October 2025, and patient enrollment began in the same month. Recruitment is ongoing. CONCLUSIONS The STABLE study will provide prospective evidence regarding the efficacy and safety of single-fraction 8 Gy radiotherapy for bleeding gastrointestinal malignancies. The findings may help increase access to a less burdensome hemostatic approach for patients with bleeding gastrointestinal malignancies. CLINICALTRIAL This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; UMIN000059269).

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