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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44854

Enrollment

Registered

2013-11-15

Start date

2015-02-02

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney cancer renal cell cancer Renal cell carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results