Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059406) titled 'STOP-BLEED study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing Upper Gastriointestinal Tumors' on Oct. 20.
Study Type:
Observational
Primary Sponsor:
Institute - Aichi Cancer Center Hospital
Condition:
Condition - Bleeding 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) Bleeding from a tumor in the stomach, gastroesophageal junction, or duodenum, diagnosed endoscopically or by hematemesis/melena
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 - Preinitiation
Date of protocol fixation - 2015 Year 07 Month 23 Day
Date of IRB - 2025 Year 10 Month 14 Day
Anticipated trial start date - 2025 Year 10 Month 15 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=R000067942
Disclaimer: Curated by HT Syndication.
