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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011570
Receipt No. R000012888
Scientific Title The assessment of the response to everolimus of renal cell carcinoma by FDG PET/CT and its impact on prognosis
Date of disclosure of the study information 2013/08/25
Last modified on 2017/04/29

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Basic information
Public title The assessment of the response to everolimus of renal cell carcinoma by FDG PET/CT and its impact on prognosis
Acronym FDG-PET/CT assessment of response to everolimus in renal cell carcinoma
Scientific Title The assessment of the response to everolimus of renal cell carcinoma by FDG PET/CT and its impact on prognosis
Scientific Title:Acronym FDG-PET/CT assessment of response to everolimus in renal cell carcinoma
Region
Japan

Condition
Condition advanced renal cell carcinoma (RCC)
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the relationship of the clinical outcome of patients with advanced renal cell (RCC) treated with everolimus following tyrosine kinase inhibitor (TKI) and radiological parameters obtained with FDG-PET/CT including maximum standardized uptake value (SUVmax) at baseline and change of SUVmax at four weeks after everolimus treatment onset.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between maximum standardized uptake value (SUVmax) at four weeks after everolimus treatment onset and Progression-free survival.
SUVmax: the highest SUV in all RCC lesions in the individual patient
Key secondary outcomes A.Relationship between radiological parameters (1)-(3) and clinical outcome as below is exploratory evaluated.
1. Progression-free survival
2. Overall survival
Relationship between laboratory data and prognosis
Safety (adverse events) and QoL

Radiological parameters
(1) FDG-PET/CT observation at baseline, SUVmax,(Sigma)TLG, and SUL, and tumor size
TLG: Total Lesion Glycilysis(g)=SUVmean(g/ml) x Volume(ml)
SUL (SUV corrected by lean body mass )
(2) FDG-PET/CT observation at 4W after treatment start, especially change in SUVmax, (Sigma)TLG, SUL, and tumor size.
(3) Presence/absence of new lesion

B. the association of prognosis and laboratory data

C. change of QOL by everolimus treatment

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
Other
Interventions/Control_1 Design of this study is prospective, multi-centered, single arm, interventional phase II study. Only the patients who are planned to receive everolimus treatment are enrolled in this study, and the treatment with everolimus is performed within the label of the drug as daily medical practice. Therefore the study is non-interventional in terms of treatment with everolimus. However, because the second FDG-PET/CT for evaluation of treatment efficacy is beyond the daily medical practice, this study is interventional.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following are eligible.
(1)Over 20 years old
(2)Histologically confirmed advanced/recurrent RCC
(3)Under or after treatment with 1st tyrosine kinase inhibitor (sorafenib, sunitinib, axitinib, or pazopanib)
(4)Treatment with everolimus is scheduled and the dose of everolimus at start is more or 5.0mg/day.
(5)More than one target lesion defined by RECIST (v1.1)
(6)Major organ function conserved
(7)Life expectancy of more or 12 weeks
(8)With written informed consent
Key exclusion criteria Patients who meet any of the following are excluded from the study.
(1)Concurrent antitumor treatment other than everolimus is given.
(2)Prior treatment with more or 2 tyrosine kinase inhibitors
(3)Prior treatment of treatment with mTOR inhibitors (temsirolimus or everolimus)
(4)Prior treatment with chemotherapy with antitumor drug, regardless of cytokine therapy
(5)Poorly-controlled diabetes mellitus (fasting blood glucose more than 150 g/dL)
(6)Pregnant and/or nursing woman, possibility of pregnancy
(7)History of organ transplantation (including bone marrow transplantation)
(8)History of malignancy except:
(i)Curatively treated intraepithelial cervical cancer, basal cell carcinoma, superficial bladder cancer (Ta, Tis and T1).
(ii)Patients who had been disease free more for than 3 years after curative therapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Nakaigawa
Organization Yokohama City University
Division name Department of Urology
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama, Japan
TEL 045-787-2800
Email nakaigan@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noboru Nakaigawa
Organization Yokohama City University
Division name Department of Urology
Zip code
Address 3-9 Fukuura ama Kanazawku Yokohama. Japan
TEL 045-787-2679
Homepage URL
Email nakaigan@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 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 05 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 25 Day
Last follow-up date
2018 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 23 Day
Last modified on
2017 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012888

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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