Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 19, 2026
Open Peer Review Period: Jul 23, 2026 - Sep 17, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A Multicenter Phase II Study Evaluating the Efficacy of Single-Fraction 8 Gy Radiotherapy for Bleeding Gastrointestinal Malignancies: STABLE Study Protocol
ABSTRACT
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. Clinical Trial: This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; UMIN000059269).
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