UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029110
Receipt number 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 2019/12/11 14:33:46

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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

6500017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-6302

Homepage URL


Email

komasho8@gmail.com


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



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

The Ethics Committee at Kobe university hospital

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

Tel

078-382-6669

Email

kainyu@med.kobe-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



Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033071

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31075183

Number of participants that the trial has enrolled

17

Results

Bibliography:
Validation of combination treatment with surgical spacer placement and subsequent particle radiotherapy for unresectable hepatocellular carcinoma. J Surg Oncol.2019 Aug;120(2):214-222.

Space-Making Particle Therapy with Surgical Spacer Placement in Patients with Sacral Chordoma.J Am Cill Surg. 2019 Nov 22. pii: S1072-7515(19)32220-3

Results date posted

2019 Year 12 Month 03 Day

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

Completed

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

2018 Year 11 Month 14 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 12 Month 11 Day



Link to view the page

Value
https://center6.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