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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029580
Receipt No. R000033495
Scientific Title Multicenter prospective observational study on the effectiveness of palliative radiotherapy for gastric cancer with bleeding (JROSG 17-3)
Date of disclosure of the study information 2017/10/23
Last modified on 2019/04/18

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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 Kumamoto University Hospital
Division name Department of Radiation Oncology
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
TEL 096-373-5261
Homepage URL
Email tsaito@kumamoto-u.ac.jp

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 (Kumamoto University Hospital)
Address 1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto, 860-8556, Japan
Tel 096-373-5657
Email ski-shien@jimu.kumamoto-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 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 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
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
2019 Year 04 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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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