UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003675 |
|---|---|
| Receipt number | R000004457 |
| Scientific Title | Impact of functional imaging on the evaluation of treatment effect after neoadjuvant chemoradiation therapy for non-small cell lung cancer |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2017/02/15 23:16:29 |
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Basic information
Public title
Impact of functional imaging on the evaluation of treatment effect after neoadjuvant chemoradiation therapy for non-small cell lung cancer
Acronym
Impact of functional imaging on the evaluation of treatment effect after neoadjuvant chemoradiation therapy for non-small cell lung cancer
Scientific Title
Impact of functional imaging on the evaluation of treatment effect after neoadjuvant chemoradiation therapy for non-small cell lung cancer
Scientific Title:Acronym
Impact of functional imaging on the evaluation of treatment effect after neoadjuvant chemoradiation therapy for non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect an useful index about the treatment effect prediction of neoadjuvant chemoradiation therapy for non-small cell lung cancer by evaluating of changes of functional imaging before and after neoadjuvant chemoradiation therapy and the pathological information obtained after operation.
Basic objectives2
Others
Basic objectives -Others
Utility of functional imaging about treatment effect prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of treatment effect prediction by functional imaging
Key secondary outcomes
Pathological response of preoperative therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Undergo PET/CT and plain MRI (including diffusion-weighted image) before and after neoadjuvant chemoradiation therapy.
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 confirmed Non-small cell lung cancer.
2.Adequate bone marrow function
WBC more than 4000/ul, Platelet count more than 100,000/ul.
3.Adequate liver function.
(T.Bil less than 1.5mg/dl)
4.Adequate renal level.
(serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 60mg/dl)
5.Adequate pulmonary function
(PaO2 more than 70Torr)
6. No other severe complications. Agreement for the protocol by physicians, surgeons and radiologists is essential.
7.Written informed consent to participate in the trial is necessary
Key exclusion criteria
1.Malignant pleuritis or malignant pericarditis.
2.Pleural dissemination.
3.Patients with severe complications.
a.Pulmonary fibrosis.
b.Severe heart disease.(Uncontrollable angina or myocardial infarction within the past 3 months)
c.Uncontrollable Diabetes Mellitus.
d.Severe infectious disease
e.Other unsuitable patient judged by a physician.
4.Women during pregnancy or lactating.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Otomi |
Organization
University of Tokushima
Division name
Department of radiology
Zip code
Address
2-50-1, Kuramoto-cho, Tokushima
TEL
088-633-9283
otomi.yoichi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Otomi |
Organization
University of Tokushima
Division name
Department of radiology
Zip code
Address
2-50-1, Kuramoto-cho, Tokushima
TEL
088-633-9283
Homepage URL
otomi.yoichi@tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2010 | Year | 05 | Month | 31 | 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
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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
Management information
Registered date
| 2010 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004457
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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