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Multicenter prospective observational study on the effectiveness of palliative radiotherapy for gastric cancer with bleeding (JROSG 17-3)

Not Applicable
Conditions
Gastric cancer with bleeding
Registration Number
JPRN-UMIN000029580
Lead Sponsor
Japanese Radiation Oncology Study Group (JROSG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
55
Inclusion Criteria

Not provided

Exclusion Criteria

1) Gastric cancer or locally recurrent gastric cancer after surgery was previously irradiated. 2) Patients planned to receive curative treatment for gastric cancer. 3) Patients received chemotherapy or molecular targeted therapy within 2 weeks before the planned start date of radiotherapy. 4) Patients planned to receive chemotherapy or molecular targeted therapy within 2 weeks after the planned start date of radiotherapy. 5) Patients receiving anticoagulation therapy. 6) Platelet count was less than 25,000/mm3 within 14 days before enrollment. 7) Patients with disseminated intravascular coagulation. 8) Patients with severe comorbidity (infection, heart failure, liver failure, renal failure, or connective tissue disease). 9) Patients with severe mental disease. 10) Pregnant, lactating, or planning to get pregnant during the study period.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of enrolled patients who achieve hemostasis four weeks after enrollment (intention-to-treat analysis)
Secondary Outcome Measures
NameTimeMethod
Proportion of enrolled patients who complete the planned radiotherapy, Adverse events, Change in hemoglobin level, Change in blood transfusion amount, Symptom score, Satisfaction with the intervention, Rebleeding-free interval, Overall survival, Salvage treatment for hemostasis, Performance status
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