UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034674 |
|---|---|
| Receipt number | R000039527 |
| Scientific Title | The early assessment of the response to Nivolumab of renal cell carcinoma by FDG PET/CT |
| Date of disclosure of the study information | 2018/10/29 |
| Last modified on | 2018/11/01 21:03:01 |
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Basic information
Public title
The early assessment of the response to Nivolumab of renal cell carcinoma by FDG PET/CT
Acronym
RCC PET/CT study: response to Nivolumab
Scientific Title
The early assessment of the response to Nivolumab of renal cell carcinoma by FDG PET/CT
Scientific Title:Acronym
RCC PET/CT study: response to Nivolumab
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test whether the assessment by FDG PET/CT at 4 weeks after treatment start predicts the therapeutic effect of nivolumab to advancer renal cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To test the correlation between judging by FDG PET/CT at 4 weeks after treatment start and the evaluation of therapeutic effect based on RECIST using CT scan at 16 weeks.
The criteria of judging by FDG PET/CT at 4 weeks
Responder: the case who satisfies the following conditions
1) max SUVmax increases more or 20%
2)without new lesions
Non-responder: the case who does not meet "responder"
max SUVmax: the highest SUV in the individual patient
Key secondary outcomes
To evaluate the relation between the assessment by FDG PET/CT at 4 weeks and clinical outcome as below.
1. Progression-free survival
2. Overall survival
3. Response rate
To search radiological parameter which predicts clinical outcome as below
1. Progression-free survival
2. Overall survival
3. Response rate
To search clinical parameter which predicts clinical outcome as below
1. Progression-free survival
2. Overall survival
3. Response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
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 nivolumab treatment are enrolled in this study, and the treatment with nivolumab is performed within the label of the drug as daily medical practice. Therefore the study is non-interventional in terms of treatment with nivolumab. 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 renal cell carcinoma
(3) Received the treatment by nivolumab
(4) More than one target lesion defined by RECIST (v1.1)
(5) With written informed consent
Key exclusion criteria
Patients who meet any of the following are excluded from the study.
(1) Poorly-controlled diabetes mellitus (fasting blood glucose >150mg/dL)
(2) History of organ transplantation (including bone marrow transplantation)
(3) 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
(4) Pregnant and/or nursing woman, possibility of pregnancy
(5) Patient treated simultaneously by other antineoplastic therapeutic or therapy purposing antitumor effect except for nivolumab
examples: chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, hyperthermia, surgery
(6) any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama City University Graduate School of medicine
Division name
Department of Urology
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama 2360004 Japan
TEL
045-787-2679
nakaigan@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama City University Graduate School of medicine
Division name
Department of Urology
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama 2360004 Japan
TEL
045-787-2679
Homepage URL
nakaigan@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama Coty Univeesity
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Cancer Center
Yokosuka Kyosai Hospital
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
| 2018 | Year | 10 | Month | 29 | 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
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039527
