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
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
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
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
