UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011041 |
|---|---|
| Receipt number | R000012923 |
| Scientific Title | Carbon ion radiotherapy for stage III non-small cell lung cancer |
| Date of disclosure of the study information | 2013/06/25 |
| Last modified on | 2013/06/25 21:12:17 |
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Basic information
Public title
Carbon ion radiotherapy for stage III non-small cell lung cancer
Acronym
Carbon ion radiotherapy for stage III non-small cell lung cancer
Scientific Title
Carbon ion radiotherapy for stage III non-small cell lung cancer
Scientific Title:Acronym
Carbon ion radiotherapy for stage III non-small cell lung cancer
Region
| Japan |
Condition
Condition
clinical stage III non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of carbon ion radiotherapy for clinical stage III non-small cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute adverse effect
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 III (UICC 7th) without N3 case
3.Refusal or inoperable case
4. Refusal or impossible case to perform chemotherapy
5.Measureable tumor
6.PS 0-2
7.Informed consent
Key exclusion criteria
1. pregnancy and lactation
2. past history of chemotherapy for lung cancer
3. field size more than 15 x 15 cm
4. life expectancy less than 6 months
5. Uncontrolled infection of lung
6. Active interstitial lung disease
7. Active double cancers
7. Other medical or psychological unsuitable reasons
8. T4 case without invasion to vertebral body
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
TEL
027-220-8383
Homepage URL
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Phase I study
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012923
