UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of feasibility and effectivenes of proton beam therapy followed by cryoablation for malignant lung tumors
Title of the study (Brief title)	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	Hiroaki Nomori
Organization	Kameda Medical Center
Division name	General thoracic surgery
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	Hiroaki Nomori
Organization	Kameda Medical Center
Division name	General thoracic surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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