UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000003797
Receipt No. 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 (Ver. 7)

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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
Email 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
Email tohno@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004590