UMIN-CTR Clinical Trial

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

retroperitoneal/pelvic malignancy

Classification by specialty

Gastrointestinal surgery

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院（福岡県）

Date of disclosure of the study information

2014

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

03

Month

21

Day

Last modified on

2016

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015734