Status:
COMPLETED
Active Surveillance of the Small Renal Mass
Lead Sponsor:
Yale University
Conditions:
Small Renal Mass, Kidney Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. This does not mean that the tumor i...
Detailed Description
While some patients with small kidney tumors may require eventual treatment, most do not. Therefore, the American Urologic Association considers active surveillance an acceptable treatment strategy. T...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Life expectancy \>3 years (by physician estimate)
- Measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound
- Clear cell renal cell carcinoma histology
- Renal tumor diagnosed within 6 months
- Recent biopsy (\<6 weeks) performed, if performed at an outside institution, there must be sufficient material for biomarker analysis
- No evidence of vascular invasion or regional nodal/distant disease
- Renal tumor that is able to be managed with upfront surgery
- Adequate organ function (Hemoglobin \> 9, Absolute neutrophil count (ANC) ≥ 1500/μL Platelets ≥ 100,000/μL, AST and ALT ≤3.0 upper limit of normal (ULN), total bilirubin ≤ ULN, eGFR ≥ 30
- Good Performance status (ECOG ≤2)
- Understanding and willingness to provide consent
Exclusion
- History of a hereditary renal cancer syndrome
- Tumor \>2.7 cm, stages T1b-T4
- Life expectancy \<3 years
- Presence of an active, untreated, metastatic non-renal malignancy
- Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months that would predispose to immediate surgical therapy
- Medical contraindication to upfront surgical management of renal mass
- History of bleeding diathesis or recent bleeding episode that would prevent surgical resection
- Unwillingness to undergo monitoring and imaging studies
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02204800
Start Date
December 1 2014
End Date
August 31 2020
Last Update
March 1 2021
Active Locations (1)
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1
Yale New Haven Hospital Smilow Cancer Center
New Haven, Connecticut, United States, 06510