UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059269 |
|---|---|
| Receipt number | R000067191 |
| Scientific Title | A Multicenter Phase II Study Evaluating the Efficacy of Single-Fraction 8 Gy Radiotherapy for Bleeding Gastrointestinal Malignancies |
| Date of disclosure of the study information | 2025/10/02 |
| Last modified on | 2025/10/02 16:15:41 |
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Basic information
Public title
A study to see if one session of radiation therapy can stop bleeding from cancers in the digestive tract
Acronym
STABLE study
Scientific Title
A Multicenter Phase II Study Evaluating the Efficacy of Single-Fraction 8 Gy Radiotherapy for Bleeding Gastrointestinal Malignancies
Scientific Title:Acronym
STABLE study
Region
| Japan |
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 specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the hemostatic rate after single-fraction 8 Gy radiotherapy in patients with bleeding gastrointestinal malignancies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
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.
Key secondary outcomes
- 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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single-fraction 8 Gy external beam radiotherapy for the primary or postoperative locally recurrent lesion of bleeding gastrointestinal malignancies.
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
| 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 sample size
47
Research contact person
Name of lead principal investigator
| 1st name | Nobuki |
| Middle name | |
| Last name | Imano |
Organization
Hiroshima University Hospital
Division name
Department of Radiation Oncology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
TEL
082-257-5555
imano@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Miyoshi |
Organization
Hiroshima University Hospital
Division name
Department of Radiation Oncology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
TEL
082-257-5555
Homepage URL
smiyoshi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.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
広島大学病院（広島県）、順天堂大学医学部附属順天堂医院（東京都）、広島市立北部医療センター安佐市民病院（広島県）、藤枝市立総合病院（静岡県）、浜松医科大学医学部附属病院（静岡県）、済生会熊本病院（熊本県）、広島赤十字・原爆病院（広島県）、県立広島病院（広島県）、秋田大学医学部附属病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 02 | 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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067191
