UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029580
Receipt number 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 2021/10/18 09:16:42

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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

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 or person

Institute

Japanese Radiation Oncology Study Group (JROSG)

Institute

Department

Personal name



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

Value
https://center6.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