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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000029110
Receipt No. R000033071
Scientific Title Development of spacer placement surgery for enlarging the indication of particle radiotherapy for abdominal malignancies
Date of disclosure of the study information 2017/10/01
Last modified on 2019/03/22

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Basic information
Public title Development of spacer placement surgery for enlarging the indication of particle radiotherapy for abdominal malignancies
Acronym Development of spacer placement surgery for enlarging the indication of particle radiotherapy for abdominal malignancies
Scientific Title Development of spacer placement surgery for enlarging the indication of particle radiotherapy for abdominal malignancies
Scientific Title:Acronym Development of spacer placement surgery for enlarging the indication of particle radiotherapy for abdominal malignancies
Region
Japan

Condition
Condition abdominal malignancies
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Particle radiotherapy is a promising new modality that elicits an inherent antitumor effect against various malignant tumors.However, the application of particle therapy to abdominal malignancies is strongly restricted because the tolerance dose of nearby intestines is extremely low. To overcome this limitation, we have developed a novel two-stage treatment with spacer surgery and particle therapy. The aim of the present study is to evaluate the feasibility and effectiveness of the spacer surgery and particle radiotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility and effectiveness of spacer surgery and particle radiotherapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Spacer placement surgery
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 years or older
2.Sex: Both
3.Patients eligible for particle radiotherapy who can eliminate intestines by spacer surgery
4.Patients who can pay the treatment fee
Key exclusion criteria 1.Patients who cannnot endure open surgery
2.Patients who are pregnant
3.Patients who do not agree with the treatment
4.Patients whom the doctors judge as unsuitable treatment
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takumi
Middle name
Last name Fukumoto
Organization Kobe University Graduate School of Medicine
Division name Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-6302
Email fukumoto@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name SHOHEI
Middle name
Last name KOMATSU
Organization Kobe University Graduate School of Medicine
Division name Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code 6500004
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-6302
Homepage URL
Email komasho8@gmail.com

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
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 Kobe universtiy
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel 078-382-6302
Email komasho8@gmail.com

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
2017 Year 10 Month 01 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 Suspended
Date of protocol fixation
2007 Year 01 Month 09 Day
Date of IRB
2007 Year 01 Month 09 Day
Anticipated trial start date
2007 Year 01 Month 09 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033071

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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