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Recruitment status Terminated
Unique ID issued by UMIN UMIN000026423
Receipt No. 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

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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
Institute Kameda Medical Center
General thoracic surgery
Institute
Department

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
URL(English) https://upload.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


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