Gastric cancer with bleeding
Conditions
Interventions
None listed
Sponsors
Japanese Radiation Oncology Study Group (JROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years old or over. 2) Patients with a pathological diagnosis of gastric cancer. 3) Bleeding from gastric cancer or locally recurrent gastric cancer after surgery (diagnosed by gastroscopy, or by melena or hematemesis). 4) Gastric cancer or locally recurrent gastric cancer after surgery can be identified by diagnostic imaging, directly or by marking with a clip. 5) Patients received blood transfusion, or hemoglobin level was less than 8.0 g/dL , within 4 weeks before enrollment. 6) Patients without bleeding from lesions other than gastric cancer or locally recurrent gastric cancer after surgery. 7) Patients with ECOG performance status score 0-3. 8) Signed informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of enrolled patients who achieve hemostasis four weeks after enrollment (intention-to-treat analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTetsuo Saito
Arao Municipal Hospital Department of Radiation Oncology
Outcome results
None listed