Status:
COMPLETED
IMaging PAtients for Cancer Drug selecTion - Renal Cell Carcinoma (IMPACT-RCC)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Clear-cell Metastatic Renal Cell Carcinoma
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
Rationale. In part of the patients with good and intermediate risk metastatic renal cell carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is not necessary. By no...
Eligibility Criteria
Inclusion
- Histological or cytological documented mRCC 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:
- Karnofsky performance \<80
- Time from diagnosis detection of metastases \< 1 year
- Haemoglobin \< lower limit of normal (LLN)
- Corrected calcium \> upper limit of normal (ULN)
- Neutrophils \> ULN
- 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)
- Time from diagnosis of metastases \< 3 months
- Able to provide written informed consent
- Age ≥ 18 years
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02228954
Start Date
December 1 2014
End Date
October 19 2021
Last Update
December 7 2021
Active Locations (3)
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1
VU University Medical Center
Amsterdam, Netherlands
2
University Medical Center Groningen
Groningen, Netherlands
3
Radboudumc
Nijmegen, Netherlands, 6525GA