UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003797 |
|---|---|
| Receipt number | R000004590 |
| Scientific Title | Carbon ion radiotherapy for stage I non-small cell lung cancer |
| Date of disclosure of the study information | 2010/06/21 |
| Last modified on | 2020/07/01 15:08:16 |
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Basic information
Public title
Carbon ion radiotherapy for stage I non-small cell lung cancer
Acronym
Carbon ion radiotherapy for stage I non-small cell lung cancer
Scientific Title
Carbon ion radiotherapy for stage I non-small cell lung cancer
Scientific Title:Acronym
Carbon ion radiotherapy for stage I non-small cell lung cancer
Region
| Japan |
Condition
Condition
clinical stage I non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of carbon ion radiotherapy in 4 fractions for clinical stage I non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
local control rate at 2 years
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven non-small cell lung cancer
2.Clinical stage I (UICC 7th), peripheral type
3.Refusal or inoperable case
4.Measureable tumor
5.PS 0-2
6.Informed consent
Key exclusion criteria
1. past history of irradiation to the target
2. past history of chemotherapy within 4 weeks before treatment
3. life expectancy less than 6 months
4. Uncontrolled infection of lung
5. Active interstitial lung disease
6. Active double cancers
7. Other medical or psychological unsuitable reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8383
tohno@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8383
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
organizing budget
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
Gunma University Clinical Research
Address
3-39-22 Showa, Maebashi
Tel
027-220-8740
khirooka@showa.gunma-u.ac.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
| 2010 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31532584/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31532584/
Number of participants that the trial has enrolled
37
Results
The median follow-up period was 56.3 months for all patients and 62.2 months for living patients. The actuarial 2-year, 3-year, and 5-year local control rates were 91.2%, 88.1%, and 88.1%, respectively. The actuarial 2-year, 3-year, and 5-year overall survival rates were 91.9%, 80.0%, and 74.9%, respectively. No patients with T1 disease experienced toxicities in grade 2 or worse severity.
Results date posted
| 2020 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Total number of patient: 37
Male:Female=25:12
Median age:73 (range, 47-85)
PS0:1:2=17:18:2
T1a:T1b:T2a=12:12:13
Participant flow
Informed consent-confirmation of eligibility-enrollment
Adverse events
No patients experienced toxicity with severity classified
as grade 4 or higher. One patient with severe emphysema
developed grade 3 pneumonitis, and another with bronchiectasis and atypical mycobacteriosis developed grade 2 pneumonitis. Pneumonitis of grade 2 severity or higher showed a cumulative incidence of 5%.
Outcome measures
The primary endpoint was defined as the 2-year local control rate. The secondary endpoints were defined as overall survival and progression free survival rates, occurrences of acute and late adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2010 | Year | 06 | Month | 21 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004590
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