UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective observational study on the effectiveness of palliative radiotherapy for gastric cancer with bleeding (JROSG 17-3)
Acronym	Multicenter prospective observational study on the effectiveness of palliative radiotherapy for gastric cancer with bleeding (JROSG 17-3)
Scientific Title	Multicenter prospective observational study on the effectiveness of palliative radiotherapy for gastric cancer with bleeding (JROSG 17-3)
Scientific Title:Acronym	Multicenter prospective observational study on the effectiveness of palliative radiotherapy for gastric cancer with bleeding (JROSG 17-3)
Region	Japan

Condition
Condition	Gastric cancer with bleeding
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of palliative radiotherapy for gastric cancer with bleeding
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of enrolled patients who achieve hemostasis four weeks after enrollment (intention-to-treat analysis)
Key secondary outcomes	Proportion of enrolled patients who complete the planned radiotherapy, Adverse events, Change in hemoglobin level, Change in blood transfusion amount, Symptom score, Satisfaction with the intervention, Rebleeding-free interval, Overall survival, Salvage treatment for hemostasis, Performance status

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) 20 years old or over. 2) Patients with a pathological diagnosis of gastric cancer. 3) Bleeding from gastric cancer or locally recurrent gastric cancer after surgery (diagnosed by gastroscopy, or by melena or hematemesis). 4) Gastric cancer or locally recurrent gastric cancer after surgery can be identified by diagnostic imaging, directly or by marking with a clip. 5) Patients received blood transfusion, or hemoglobin level was less than 8.0 g/dL , within 4 weeks before enrollment. 6) Patients without bleeding from lesions other than gastric cancer or locally recurrent gastric cancer after surgery. 7) Patients with ECOG performance status score 0-3. 8) Signed informed consent.
Key exclusion criteria	1) Gastric cancer or locally recurrent gastric cancer after surgery was previously irradiated. 2) Patients planned to receive curative treatment for gastric cancer. 3) Patients received chemotherapy or molecular targeted therapy within 2 weeks before the planned start date of radiotherapy. 4) Patients planned to receive chemotherapy or molecular targeted therapy within 2 weeks after the planned start date of radiotherapy. 5) Patients receiving anticoagulation therapy. 6) Platelet count was less than 25,000/mm3 within 14 days before enrollment. 7) Patients with disseminated intravascular coagulation. 8) Patients with severe comorbidity (infection, heart failure, liver failure, renal failure, or connective tissue disease). 9) Patients with severe mental disease. 10) Pregnant, lactating, or planning to get pregnant during the study period.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naoto Middle name Last name Shikama
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Radiation Oncology
Zip code	113-8431
Address	2-1-1 Hongo, Bunkyo-ku Tokyo 113-8421, Japan
TEL	03-3813-3111
Email	nshikama0525@gmail.com

Public contact
Name of contact person	1st name Tetsuo Middle name Last name Saito
Organization	Arao Municipal Hospital
Division name	Department of Radiation Oncology
Zip code	864-0041
Address	2600, Arao, Arao-shi, Kumamoto
TEL	0968-63-1115
Homepage URL
Email	tetsuosaito1977@gmail.com

Sponsor
Institute	Japanese Radiation Oncology Study Group (JROSG)
Institute
Department

Funding Source
Organization	Japanese Radiation Oncology Study Group (JROSG)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional review board (Arao Municipal Hospital)
Address	2600, Arao, Arao-shi, Kumamoto, 864-0041, Japan
Tel	0968-63-1115
Email	ide@hospital.arao.kumamoto.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

ひたちなか総合病院（茨城県） 市立長浜病院（滋賀県） 神戸大学医学部附属病院（兵庫県） 自治医科大学附属さいたま医療センター（埼玉県） 兵庫県立がんセンター（兵庫県） 関西医科大学（大阪府） 国立病院機構京都医療センター（京都府） 鳥取大学（鳥取県） 都立駒込病院（東京都） 藤枝市立総合病院（静岡県） 愛知県がんセンター中央病院（愛知県） 熊本大学医学部附属病院（熊本県） 順天堂大学院医学研究科（東京都） 順天堂大学医学部附属浦安病院（千葉県） 東北大学大学院医学系研究科（宮城県） 帝京大学医学部附属溝口病院（神奈川県） 埼玉医科大学総合医療センター（埼玉県） 杏林大学医学部付属病院（東京都） KKR札幌医療センター（北海道） 国立がん研究センター東病院（千葉県） 獨協医科大学越谷病院（埼玉県） 富山大学附属病院（富山県） 静岡がんセンター（静岡県） 琉球大学医学部附属病院（沖縄県） 聖隷三方原病院（静岡県） 総合南東北病院（福島県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	55
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	Main results already published
Date of protocol fixation	2017 Year 09 Month 21 Day
Date of IRB	2017 Year 10 Month 12 Day
Anticipated trial start date	2017 Year 10 Month 23 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study Design: A multicenter prospective observational study Primary outcome: Proportion of enrolled patients who achieve hemostasis four weeks after enrollment (intention-to-treat analysis) A patient is judged to achieve hemostasis when all of the following criteria are met: (1) consecutive seven days with no blood transfusion within four weeks after enrollment, (2) no salvage treatment for hemostasis (surgery, endoscopic treatment, transcatheter embolization, reirradiation) within four weeks after enrollment, and (3) hemoglobin level 8.0 g/dL or greater at four weeks after enrollment.

Management information
Registered date	2017 Year 10 Month 16 Day
Last modified on	2021 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033495