Bleeding primary or postoperative locally recurrent solid malignant tumors of the gastrointestinal tract (esophagus, stomach, duodenum, small intestine, colon, rectum, and anus
Conditions
Interventions
Single-fraction 8 Gy external beam radiotherapy for the primary or postoperative locally recurrent lesion of bleeding gastrointestinal malignancies.
Sponsors
Hiroshima University
Juntendo University Hospital Hiroshima City North Medical Center Asa Citizens Hospital Fujieda Municipal General Hospital Hamamatsu University School of Medicine Hospital Saiseikai Kumamoto Hospital Hiroshima Red Cross Hospital &
Atomic-bomb Survivors Hospital Hiroshima Prefectural Hospital Akita University Hospital National Cancer Center Hospital Jichi Medical University Hospital Wakayama Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Pathologically diagnosed* with solid tumor (hematologic malignancies such as lymphoma or multiple myeloma are excluded) * For postoperative local recurrence, pathological diagnosis at the time of initial treatment is acceptable 3. Bleeding from the primary lesion of a gastrointestinal malignancy (esophagus, stomach, duodenum, small intestine, colon, rectum, anus) or from a postoperative local recurrent lesion of gastrointestinal malignancy, diagnosed by endoscopy or by hematemesis, melena, or bloody stool 4. Received blood transfusion for tumor bleeding within 4 weeks before registration, or hemoglobin level <8.0 g/dL in a blood test within 4 weeks before registration 5. No prior hemostatic treatment by surgery, endoscopy, or endovascular therapy, or such treatment was performed but was ineffective 6. No confirmed active bleeding from sites other than the target lesion for study treatment 7. No prior radiotherapy to the planned treatment field 8. No curative treatment planned for the target lesion of the study treatment 9. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-3 10. Written informed consent obtained
Exclusion criteria
Exclusion criteria: 1. Patients receiving anticoagulant therapy 2. Platelet count <25,000/mm3 3. Diagnosed with disseminated intravascular coagulation (DIC) 4. Serious comorbidities (any of infection, heart failure, liver failure, renal failure, or collagen disease) 5. Clinically significant psychiatric disorder 6. Pregnant, breastfeeding, or possibly pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis rate (ITT analysis; assessment at 4 weeks +/- 1 week from treatment start) Hemostasis is defined as meeting all of the following: 1. No blood transfusion during the 14 days prior to the efficacy assessment date. 2. No procedures intended to control bleeding for the index lesion between the radiotherapy date and the assessment date (i.e., surgery, endoscopic hemostasis, trans-arterial embolization, or any radiotherapy other than the study treatment). 3. Hemoglobin greater than or equal to 8.0 g/dL at the time of assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Hemostasis rate: assessed in ITT at Week 2 (+/-1 week) and Week 8 (+/-2 weeks); in PP at Week 2 (+/-1 week), Week 4 (+/-1 week), and Week 8 (+/-2 weeks) - Use of antiemetics: record presence/absence, timing, drug name, and dose from pre-registration assessment to 2 weeks after treatment start - Change in hemoglobin: difference from baseline at Week 2 (+/-1 week), Week 4 (+/-1 week), and Week 8 (+/-2 weeks) - Change in transfusion volume: for Week 4 assessment, compare total transfusion volume during 20 days before vs 20 days after treatment start; for Week 8 assessment, compare during 40 days before vs 40 days after - Rebleeding rate: among patients with hemostasis, evaluate presence of rebleeding as per protocol definition - Time to rebleeding: time from first hemostasis to rebleeding; deaths censored - Salvage hemostatic treatment: record presence/absence of surgery, endoscopic hemostasis, embolization, or radiotherapy for the target lesion; in applicable cases, assess hemostasis at Week 4 (+/-1 week) from salvage treatment - Overall survival: from registration to death from any cause - Symptom score: NRS (0-10) for nausea, appetite loss, fatigue, dyspnea, pain, and stress at baseline, Week 1 (+/-3 days), Week 2 (+/-1 week), Week 4 (+/-1 week), and Week 8 (+/-2 weeks) - QOL score: EQ-5D-5L at baseline, Week 2 (+/-1 week), Week 4 (+/-1 week), Week 8 (+/-2 weeks), and Month 6 (+/-1 month) - Adverse events: graded per CTCAE v5.0 (JCOG Japanese translation) | — |
Countries
Japan
Contacts
Public ContactShota Miyoshi
Hiroshima University Hospital Department of Radiation Oncology
Outcome results
None listed