UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026423
Receipt number R000030296
Scientific Title Prospective study of feasibility and effectivenes of proton beam therapy followed by cryoablation for malignant lung tumors
Date of disclosure of the study information 2017/03/06
Last modified on 2018/03/06 18:15:04

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Basic information

Public title

Prospective study of feasibility and effectivenes of proton beam therapy followed by cryoablation for malignant lung tumors

Acronym

Study of feasibility and effectiveness of proton beam therapy followed by cryoablation for lung tumors

Scientific Title

Prospective study of feasibility and effectivenes of proton beam therapy followed by cryoablation for malignant lung tumors

Scientific Title:Acronym

Study of feasibility and effectiveness of proton beam therapy followed by cryoablation for lung tumors

Region

Japan


Condition

Condition

Malignant lung tumors

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Feasibility and effectiveness of proton beam therapy followed by cryoablation for malignant lung tumors are examined.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Complications after treatment.

Key secondary outcomes

Local control and overall survival more than 2 years after treatment.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

10 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Peripheral primary or metastatic lung tumors larger than 2 cm.
2. Tumors located near lung hilum including less than 2 cm.
3. Tumor local control is not expected by surgery, chemotherapy or conventional radiation therapy.
4. Patients who request cryoablation after radiation therapy, even if tumors could be cured by surgery.
5. Patients who request cryoablation after proton beam therapy rather than cryoablation after stereotactic radiation therapy.
6. Patients with multiple lung metastases whose prognosis could be prolonged by a part of tumors is treated by cryoablation after proton beam therapy.
7. Patients who give informed consent for risk and prognosis after cryoablation after proton beam therapy.

Key exclusion criteria

1. Patients with moderate interstitial pneumonia.
2. Patients who suffered radiation pneumonia after proton beam therapy.
3. Patients with another primary tumors.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Nomori

Organization

Kameda Medical Center

Division name

General thoracic surgery

Zip code


Address

929 Higashi-cho Kamogawa City, Chiba, 296-8602

TEL

0470-92-2211

Email

hnomori@qk9.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Nomori

Organization

Kameda Medical Center

Division name

General thoracic surgery

Zip code


Address

929 Higashi-cho Kamogawa City, Chiba, 296-8602

TEL

0470-92-2211

Homepage URL


Email

hnomori@qk9.so-net.ne.jp


Sponsor or person

Institute

Kameda Medical Center
General thoracic surgery

Institute

Department

Personal name



Funding Source

Organization

None

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


Address


Tel


Email



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

亀田総合病院(千葉県)


Other administrative information

Date of disclosure of the study information

2017 Year 03 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

Terminated

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 06 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

Nothing particulate.


Management information

Registered date

2017 Year 03 Month 06 Day

Last modified on

2018 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030296


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name