UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030056
Receipt number R000034320
Scientific Title A phase II trial of Decompression Surgery and Postoperative Stereotactic Body Radiotherapy for Metastatic Epidural Spinal Cord Compression
Date of disclosure of the study information 2017/11/21
Last modified on 2021/07/21 00:06:49

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Basic information

Public title

A phase II trial of
Decompression Surgery and Postoperative Stereotactic Body Radiotherapy for Metastatic Epidural Spinal Cord Compression

Acronym

Decompression Surgery and Postoperative SBRT for MESCC

Scientific Title

A phase II trial of
Decompression Surgery and Postoperative Stereotactic Body Radiotherapy for Metastatic Epidural Spinal Cord Compression

Scientific Title:Acronym

Decompression Surgery and Postoperative SBRT for MESCC

Region

Japan


Condition

Condition

Metastatic Epidural Spinal Cord Compression

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and toxicity of decompression surgery and postoperative stereotactic body radiotherapy for metastatic epidural spinal cord compression.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Local control at 1 year

Key secondary outcomes

Ambulatory function, OS, local progression free survival, pattern of failure, pain response, Adverse events, QOL


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Surgical decompression and postoperative stereotactic body radiotherapy of 24 Gy in 2 fractions.

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. pathological or clinical diagnosis of primary cancer (including sarcoma)
2. spine metastases confirmed by images
3. Symptoms by the tumor
4. Bilsky grade is more than Ib
5. Age; 20-
6. Other lesions are controlled, or the lesion was irradiated previously
7. prognosis is expected more than 6 months
8. Written informed consent

Key exclusion criteria

1. Radiosensitive histology
2. the lesion was irradiated within 3 months
3. the lesion was treated with SBRT
4. untlerable to surgery
5. complete paralysis more than 48 hours
6. impossible to conduct decompression surgery

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Hozumi

Organization

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Division name

Orthopedic surgery

Zip code

113-8677

Address

3-18-22 Honkomagome, Bunkyo-ku,Tokyo

TEL

03-3823-2101

Email

t.hoz@cick.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Ito

Organization

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Division name

Division of Radiation Oncology, Department of Radiology

Zip code

113-8677

Address

3-18-22 Honkomagome, Bunkyo-ku,Tokyo

TEL

03-3823-2101

Homepage URL

http://www.cick.jp/houshasenchiryou/housha_shiken/

Email

keiito@cick.jp


Sponsor or person

Institute

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Institute

Department

Personal name



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

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Address

Hon-komagome 3-18-22, Bunkyo-ku

Tel

0338232101

Email

rinri@cick.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 11 Month 21 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

33

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 10 Month 10 Day

Date of IRB

2017 Year 11 Month 20 Day

Anticipated trial start date

2017 Year 11 Month 20 Day

Last follow-up date

2020 Year 10 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 11 Month 21 Day

Last modified on

2021 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name