Watchful waiting in patients with good and intermediate risk metastatic renal cell carcinoma; an imaging guided observational approach

Completed

• Conditions: kidney cancer; renal cell cancer; Renal cell carcinoma; 10038364

• Registration Number: NL-OMON44854
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: time to mccRCC progression under watchful waiting as assessed<br /><br>by CT-scans (2, 4, 6, 9, 12 months in year 1 and thereafter every 4 months<br /><br>until progressive disease) criteria. </p><br>