Bleeding Gastrointestinal Tumors
Conditions
Interventions
None listed
Sponsors
Aichi Cancer Center Hospital
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) Bleeding from a tumor in the stomach, gastroesophageal junction, or duodenum, diagnosed endoscopically or by hematemesis/melena 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
| Measure | Time frame |
|---|---|
| Changes in quality of life (EORTC QLQ-C15-PAL, EuroQOL EQ-5D-5L) at 2 weeks Hemostatic response rate at 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL (outside primary evaluation period), treatment completion rate, adverse events, change in hemoglobin levels, change in blood transfusion volume, timing and regimens of systemic therapy, time to first rebleeding, overall survival, salvage therapy for rebleeding, comparison of hemostatic efficacy with past treatment outcomes (vs. retrospective cohort) | — |
Countries
Japan
Contacts
Public ContactYutaro Koide
Aichi Cancer Center Hospital Department of Radiation Oncology
Outcome results
None listed