UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018573
Receipt number R000021496
Scientific Title Prospective study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors
Date of disclosure of the study information 2015/08/06
Last modified on 2019/10/02 11:27:33

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Basic information

Public title

Prospective study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors

Acronym

Prospective study of cryoablation after radiation therapy for malignant lung tumors

Scientific Title

Prospective study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors

Scientific Title:Acronym

Prospective study of cryoablation after radiation therapy for malignant lung tumors

Region

Japan


Condition

Condition

primary lung cancer, metastatic lung cancer

Classification by specialty

Pneumology Chest surgery Operative medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The safety and efficacy of cryoablation after radiotherapy for malignant lung tumors larger than 2 cm in size are prospectively studied.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Side effect and local control rate by cryoablation after radiotherapy for malignant lung tumors

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

Maneuver

Interventions/Control_1

Cryoablation is conducted after radiotherapy for malignant lung tumors larger than 2cm.Study duration is from July 2015 to March 2020.

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

15 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Malignant lung tumors larger than 2cm.

Key exclusion criteria

Patients who are not torelable for radiotherapy and cryoablation therapy.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Nomori

Organization

Kameda Medical Center

Division name

Thoracic Surgery

Zip code

296-8602

Address

929 Higashi-cho, Komogawa city, Chiba

TEL

04-7092-2211

Email

hnomori@qk9.so-net.ne.jp


Public contact

Name of contact person

1st name Harue
Middle name
Last name Tachibana

Organization

Kameda Medical Center

Division name

Review Board of Clinical Research

Zip code

296-8602

Address

929 Higashi-cho, Kamogawa city, Chiba

TEL

04-7092-2211

Homepage URL


Email

clinical_research@kameda.jp


Sponsor or person

Institute

Kameda Medical Center

Institute

Department

Personal name



Funding Source

Organization

Kameda Medical Center

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

Kameda Medical Center

Address

HIgashi-cho 929, Kamogawa city, Chiba perfecture

Tel

0470-92-2211

Email

hnomori@qk9.so-net.ne.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

2015 Year 08 Month 06 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

Completed

Date of protocol fixation

2015 Year 06 Month 17 Day

Date of IRB

2015 Year 08 Month 01 Day

Anticipated trial start date

2015 Year 08 Month 06 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 06 Day

Last modified on

2019 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name