UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045721
Receipt number R000052194
Scientific Title Phase II study of stereotactic radiotherapy for kidney cancer using an MR-Linac system
Date of disclosure of the study information 2021/10/29
Last modified on 2025/04/14 10:19:47

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Basic information

Public title

Phase II study of stereotactic radiotherapy for kidney cancer using an MR-Linac system

Acronym

MR-Linac based stereotactic radiotherapy for kidney cancer

Scientific Title

Phase II study of stereotactic radiotherapy for kidney cancer using an MR-Linac system

Scientific Title:Acronym

MR-Linac based stereotactic radiotherapy for kidney cancer

Region

Japan


Condition

Condition

Kidney cancer(primary kidney cancer)

Classification by specialty

Urology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of MR-Linac based stereotactic radiotherapy for primary kidney cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

One-year local control and the rate of occurrence of serious adverse event.

Key secondary outcomes

One-year overall survival and 1-year progression free survival


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

MR-Linac based stereotactic radiotherapy

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)Primary kidney cancer which has pathological diagnosis or clinical diagnosis
(2)T1N0M0, or T1NanyMany and all lymph nodes and distant metastases have been controlled
(3)Performance status is from 0 to 2
(4)Twenty or more years old
(5)Urologists and radiologists agree to perform stereotactic radiotherapy instead of surgery or cryotherapy, or patient refused surgery and cryotherapy.
(6)Written informed consent

Key exclusion criteria

(1)Radiation oncologists judge not to have a tolerance or not to be suitable for stereotacitc radiotherapy because of coexisting illness
(2)Double cancer or past history of double cancer within 3 years.
(3)Implanted metal in the body
(4)Mental disorder, especially claustrophobiady
(5)Infection
(6)Pregnant or lactating woman, likelihood of pregnancy

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Takaya
Middle name
Last name Yamamoto

Organization

Tohoku University Hospital

Division name

Department of Radiation Oncology

Zip code

9808575

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

+81-22-717-7312

Email

takaya.yamamoto.c3@tohoku.ac.jp


Public contact

Name of contact person

1st name Noriyoshi
Middle name
Last name Takahashi

Organization

Tohoku University Hospital

Division name

Department of Radiation Oncology

Zip code

9808575

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

+81-22-717-7312

Homepage URL


Email

noriyoshi.08.25@gmail.com


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Tohoku Certified Review Board of Tohoku University

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Japan

Tel

022-728-4105

Email

rinri-2@proj.med.tohoku.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

2021 Year 10 Month 29 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

No longer recruiting

Date of protocol fixation

2021 Year 10 Month 11 Day

Date of IRB

2021 Year 11 Month 10 Day

Anticipated trial start date

2022 Year 03 Month 01 Day

Last follow-up date

2027 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 10 Month 11 Day

Last modified on

2025 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052194