UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061784 |
|---|---|
| Receipt number | R000070708 |
| Scientific Title | STOP-BLEED 2 study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing from Non-Upper Gastrointestinal Tumors |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 16:01:16 |
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Basic information
Public title
STOP-BLEED 2 study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing from Non-Upper Gastrointestinal Tumors
Acronym
STOP-BLEED 2 study
Scientific Title
STOP-BLEED 2 study: Single-fraction RadioTherapy and Observation for Palliation of BLEEDing from Non-Upper Gastrointestinal Tumors
Scientific Title:Acronym
STOP-BLEED 2 study
Region
| Japan |
Condition
Condition
Bleeding Non-Upper Gastrointestinal Tumors
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Geriatrics |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Oral surgery |
| Blood transfusion | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate changes in quality of life and hemostatic efficacy following a single 8 Gy palliative radiation therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in quality of life (EORTC QLQ-C15-PAL, EuroQOL EQ-5D-5L) at 2 weeks
Hemostatic response rate at 2 weeks
Key secondary outcomes
QOL (outside primary evaluation period), treatment completion rate, adverse events, change in hemoglobin levels, change in blood transfusion volume, timingsystemic therapy, time to first rebleeding, overall survival, salvage therapy for rebleeding, comparison of hemostatic efficacy with past treatment outcomes vs prospective cohort data
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yutaro |
| Middle name | |
| Last name | Koide |
Organization
Aichi Cancer Center
Division name
Department of Radiation Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa, Nagoya, Aichi, Japan
TEL
0527626111
ykoide@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Koide |
Organization
Aichi Cancer Center
Division name
Department of Radiation Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa, Nagoya, Aichi, Japan
TEL
0527626111
Homepage URL
ykoide@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Yutaro Koide
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden, Chikusa, Nagoya, Aichi, Japan
Tel
0527626111
irb@aich-cc.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Prospective Cohort]
The following items will be collected based on this reference date.
Completion of the QOL questionnaires is planned four times in total.
Pre-registration (-Day 0): QOL questionnaires, PRO-CTCAE, hemoglobin level, and other treatments for the bleeding target lesion
During irradiation (Day 1-3): QOL questionnaires and PRO-CTCAE
1 week post-RT (Day 7): QOL questionnaires, PRO-CTCAE, adverse events, hemoglobin level, and other treatments for the bleeding target lesion
2 weeks post-RT (Day 14): QOL questionnaires, PRO-CTCAE, adverse events, hemoglobin level, and other treatments for the bleeding target lesion
[Retrospective Cohort]
Data will be collected from patients who received palliative radiotherapy for tumor bleeding between September 2014 and June 2025, including:
Pre-radiotherapy bleeding status
Details of hemostatic radiotherapy
Post-radiotherapy hemostatic status
Date of final follow-up and date of death
Definition of Hemostasis
Because anemia may persist despite tumor bleeding being controlled by post-radiotherapy systemic therapy, hemostasis will be judged as achieved if either cosatisfied.
(A) Without systemic therapy after radiotherapy:
All of the following conditions must be met:
No blood transfusion between Day 7 and the evaluation date at 2 weeks (+/-3 days)
No salvage treatment for the target bleeding lesion from registration to the evaluation date
Hemoglobin >=8.0 g/dL at the evaluation
(B) With systemic therapy initiated or resumed after radiotherapy:
All of the following conditions must be met:
No blood transfusion between Day 7 and the evaluation date at 2 weeks (+/-3 days)
No salvage treatment for the target bleeding lesion from registration to the evaluation date
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070708
