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STOP-BLEED 2 study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing from Non-Upper Gastrointestinal Tumors

STOP-BLEED 2 study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing from Non-Upper Gastrointestinal Tumors - STOP-BLEED 2 study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061784
Enrollment
150
Registered
2026-06-03
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Non-Upper Gastrointestinal Tumors

Interventions

None listed

Sponsors

Aichi Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 20 or older 2) Pathologically diagnosed with malignant neoplasm (primary organ/site not specified) 3) Cancer-related bleeding originating from sites other than the upper gastrointestinal tract (stomach, gastroesophageal junction, and duodenum), diagnosed either macroscopically or through symptoms such as hematemesis, bloody stools, hematuria, or abnormal bleeding 4) A single palliative radiation dose of 8 Gy is planned for the target lesion for hemostatic purposes 5) Written informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1) Surgery, endoscopic treatment, or vascular embolization is scheduled for the target lesion requiring hemostasis 2) Diagnosed with DIC (disseminated intravascular coagulation) or severe infection 3) Unable to respond or write due to poor general condition or other factors

Design outcomes

Primary

MeasureTime frame
Changes in quality of life (EORTC QLQ-C15-PAL, EuroQOL EQ-5D-5L) at 2 weeks Hemostatic response rate at 2 weeks

Secondary

MeasureTime frame
QOL (outside primary evaluation period), treatment completion rate, adverse events, change in hemoglobin levels, change in blood transfusion volume, timingsystemic therapy, time to first rebleeding, overall survival, salvage therapy for rebleeding, comparison of hemostatic efficacy with past treatment outcomes vs prospective cohort data

Countries

Japan

Contacts

Public ContactYutaro Koide

Aichi Cancer Center Department of Radiation Oncology

ykoide@aichi-cc.jp0527626111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026