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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011041
Receipt No. R000012923
Official scientific title of the study 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

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Basic information
Official scientific title of the study Carbon ion radiotherapy for stage III non-small cell lung cancer
Title of the study (Brief title) 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 Takashi Nakano
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Address 3-39-22 Showa, Maebashi, Gunma
TEL
Email

Public contact
Name of contact person Takashi Nakano
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Address
TEL 027-220-8383
Homepage URL
Email

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 25 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012923

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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