ObjectivesPrimary objective: To assess the added value of FDG-PET and 89Zr-Girentuximab-PET results measured at presentation to predict time to progression under watchful waiting in patients with good or intermediate prognosis mccRCC who are…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: time to mccRCC progression under watchful waiting as assessed
by CT-scans (2, 4, 6, 9, 12 months in year 1 and thereafter every 4 months
until progressive disease) criteria.
Secondary outcome
Secondary aims and endpoints
a) To evaluate patient therapy choice, satisfaction and quality of life at 2,
4, 6, 9, 12 months during watchful waiting.
b) To assess quality of life every three months during therapy.
c) To assess treatment response at 3 months following any treatment according
to RECIST1.1 criteria using CT-scans.
d) To assess the progression free survival defined as the period between study
entry and documented progressive disease within the watchful waiting period.
e) To assess the treatment related progression free survival defined as the
time from the start of one of the treatments until the moment of documented
tumor progression according to RECIST1.1 or death.
f) To assess overall survival, defined as the period between study entry and
death.
g) To correlate baseline PET measurements with PFS following any treatment.
h) To correlate histology, immunology, biomarkers and germline characteristics
with natural behaviour of the tumor during the watchful waiting period, and
with treatment response following any treatment.
i) To evaluate long term steady state levels of pazopanib or sunitinib with
regard to response duration on treatment.
j) To correlate CAIX status of the tumors with 89Zr-girentuximab uptake.
k) time to mccRCC progression under watchful waiting as assessed by CT-scans
(2, 4, 6, 9, 12 months in year 1 and thereafter every 4 months until
progressive disease) criteria. Rapid progression is defined as PD within 2
months and prolonged indolent disease as SD for >= 1 year after the baseline
scans.
Background summary
Rationale
In part of the patients with good and intermediate risk metastatic renal cell
carcinoma (RCC) the disease course is indolent and immediate start of systemic
therapy is not necessary. By now, we are not able to identify those patients
with indolent disease and the minor group of patients with rapidly progressive
disease. In patients with indolent disease, a watchful waiting period is
preferred, since their quality of life will not be unnecessary hampered by
adverse events and therapy resistance is not induced. This study aims to
identify those patients for whom a watchful waiting period is possible by
molecular imaging. Furthermore several types of systemic therapy are possible
once the progression is proven. These systemic treatments are comparable in
terms of efficacy, but not in terms of toxicity and their impact on quality of
life.
Study objective
Objectives
Primary objective: To assess the added value of FDG-PET and
89Zr-Girentuximab-PET results measured at presentation to predict time to
progression under watchful waiting in patients with good or intermediate
prognosis mccRCC who are eligible for watchful waiting.
Study design
Study design
This is a multicenter non-blinded prospective observational study in 40 good
and intermediate prognosis mccRCC patients.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness
At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed.
During the watchful waiting period CT*s will be made. During therapy, follow-up
will include standard laboratory analysis, and CT-scans on regular visits to
the outpatient clinic. Side effects of the medication and adverse events as a
consequence of the tumor biopsies may occur. The radiation exposure of both PET
investigations is acceptable and requires no shielding after injection of
89Zr-labelled girentuximab. Patients may benefit from disease regression or
stabilization. All three treatment choices has proven clinical benefit in this
patient population.
Geert Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Able to provide written informed consent
- Age >= 18 years
- Histological or cytological documented RCC with a clear cell component
- Good or intermediate prognosis, defined as none (good risk) or 1-2 (intermediate risk) of the below mentioned risk factors (6):
o Karnofsky performance <80
o Time from diagnosis detection of metastases < 1 year
o Haemoglobin < lower limit of normal (LLN)
o Corrected calcium > upper limit of normal (ULN)
o Neutrophils > ULN
o Platelets > ULN
- A watchful waiting period for 2 months is considered an option according to treating medical oncologist
- No prior systemic treatment for RCC (also non-adjuvant)
Exclusion criteria
- Untreated central nervous system metastases, or symptomatic intracerebral metastases.
- Pregnant or breast feeding women.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that would make the subject inappropriate for study participation including any serious condition that could interfere with subject*s safety, provision of informed consent, or compliance with study procedure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44748.091.13 |