UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of functional imaging on the evaluation of treatment effect after neoadjuvant chemoradiation therapy for non-small cell lung cancer
Title of the study (Brief title)	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	Yoichi Otomi
Organization	University of Tokushima
Division name	Department of radiology
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-633-9283
Email	otomi.yoichi@tokushima-u.ac.jp

Public contact
Name of contact person	Yoichi Otomi
Organization	University of Tokushima
Division name	Department of radiology
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-633-9283
Homepage URL
Email	otomi.yoichi@tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004457