Tokyo, Oct. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059269) titled 'A study to see if one session of radiation therapy can stop bleeding from cancers in the digestive tract' on Oct. 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Bleeding primary or postoperative locally recurrent solid malignant tumors of the gastrointestinal tract (esophagus, stomach, duodenum, small intestine, colon, rectum, and anus; excluding hematologic malignancies such as lymphoma and multiple myeloma) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the hemostatic rate after single-fraction 8 Gy radiotherapy in patients with bleeding gastrointestinal malignancies. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single-fraction 8 Gy external beam radiotherapy for the primary or postoperative locally recurrent lesion of bleeding gastrointestinal malignancies.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 47

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 27 Day Date of IRB - 2025 Year 09 Month 26 Day Anticipated trial start date - 2025 Year 10 Month 02 Day Last follow-up date - 2029 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067191

Disclaimer: Curated by HT Syndication.