Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061784) titled 'STOP-BLEED 2 study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing from Non-Upper Gastrointestinal Tumors' on June 3.
Study Type:
Observational
Primary Sponsor:
Institute - Aichi Cancer Center
Condition:
Condition - Bleeding Non-Upper Gastrointestinal Tumors
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate changes in quality of life and hemostatic efficacy following a single 8 Gy palliative radiation therapy
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Age 20 or older
2) Pathologically diagnosed with malignant neoplasm (primary organ/site not specified)
3) Cancer-related bleeding originating from sites other than the upper gastrointestinal tract (stomach, gastroesophageal junction, and duodenum), diagnosed either macroscopically or through symptoms such as hematemesis, bloody stools, hematuria, or abnormal bleeding
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
Key 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
Target Size - 150
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 02 Month 26 Day
Date of IRB - 2026 Year 06 Month 02 Day
Anticipated trial start date - 2026 Year 06 Month 03 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070708
Disclaimer: Curated by HT Syndication.
