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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013477
Receipt No. R000015734
Scientific Title A Feasibility Study of Spacer Placement to Avoid the Bowel Radiation Exposure in Carbon Ion Radiotherapy for the Treatment of Retroperitoneal/Pelvic Tumors
Date of disclosure of the study information 2014/03/24
Last modified on 2016/10/13

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Basic information
Public title A Feasibility Study of Spacer Placement to Avoid the Bowel Radiation Exposure in Carbon Ion Radiotherapy for the Treatment of Retroperitoneal/Pelvic Tumors
Acronym A Feasibility Study of Spacer Placement in Carbon Ion Radiotherapy for the Retroperitoneal/Pelvic Tumors
Scientific Title A Feasibility Study of Spacer Placement to Avoid the Bowel Radiation Exposure in Carbon Ion Radiotherapy for the Treatment of Retroperitoneal/Pelvic Tumors
Scientific Title:Acronym A Feasibility Study of Spacer Placement in Carbon Ion Radiotherapy for the Retroperitoneal/Pelvic Tumors
Region
Japan

Condition
Condition retroperitoneal/pelvic malignancy
Classification by specialty
Gastrointestinal surgery Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the safety of surgical spacer placement between the bowel and the retroperitoneal/pelvic malignancy for carbon ion radiotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intraoperative and postoperative morbidity rate
Key secondary outcomes Treatment rate of carbon ion radiotherapy, Spacer placement rate, Operative time, Blood loss, Three year local control rate, Three year overall survival rate

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
Maneuver
Interventions/Control_1 To keep the bowel away from the radiation field, the adipose tissue in the abdominal cavity or superimposed Gore-Tex sheets will be placed onto the tumor as a spacer.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Malignant tumor proven histologically or diagnosed by imaging modalities.
2. Tumor in the retroperitoneum or pelvis.
3. Unresectable tumor or the patient denies surgical removal.
4. Tumor contiguous with the bowel less than 5mm in distance.
5. No unmanageable distant metastases.
6. ECOG PS 0-2.
7. Age 20-75.
8. Adequate organ function to perform the surgery.
9. Over three months of apparent survival.
10. Written informed consent.
Key exclusion criteria 1. Tumor with over 15cm in the maximum diameter.
2. Without indication for carbon ion radiotherapy.
3. Infectious disease in abdominal or pelvic cavity.
4. Serious co-morbidity, such as cardiopulmonary disease, bleeding tendency, uncontrollable diabetes mellitus or hypertension.
5. Pregnant or possibly pregnant women.
6. Other conditions judged ineligible by physician.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Nakamura,MD
Organization Graduate School of Medical Sciences, Kyushu University
Division name Surgery and Oncology
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5437
Email mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Manabe,MD
Organization Graduate School of Medical Sciences, Kyushu University
Division name Surgery and Oncology
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5440
Homepage URL
Email manabe@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 24 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
2014 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 25 Day
Last follow-up date
2018 Year 12 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
2014 Year 03 Month 21 Day
Last modified on
2016 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015734

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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