This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide comparable local control, with similar or improved toxicity rates compared to Radio Frequency Ablation (RFA) when treating small renal cell carcinomas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
University of Michigan Hospital
Ann Arbor, Michigan, United States
Proportion of Patients With Local Control of Disease
On imaging, local control will be defined as when the treated lesion shows no enhancement.
Time frame: 12 months
Cumulative Incidence of Grade 2 and Greater Toxicities
The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).
Time frame: up to 30 days after the last study treatment
Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms
QOL scores will be summarized descriptively by treatment at each time point using the Convalescence and Recovery Evaluation (CARE) and SF-12 quality of life assessments . Any differences between treatment groups will be tested in the context of a general linear model with terms for treatment, time, treatment time and possibly other patient level covariates that might explain QOL.
Time frame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms
Patient time away from work/home secondary to treatment will be captured via patient questionnaire as a number of days and will be summarized descriptively by treatment group. Any differences between treatment groups will be tested by a two-sample t-test or nonparametric Mann-Whitney test.
Time frame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
Metastasis Free Survival Time
Time frame: 36 months post treatment
Overall Survival Time
Time frame: 36 months post treatment
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Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms
All patients will be followed to assess the development of treatment related pain, and resultant usage of analgesics (drug classification and dosage) for treatment related pain. Incidence and severity of pain will be recorded for all patients, using the Common Terminology Criteria for Adverse Events (CTCAE), as will any resultant use of analgesics, and these will be compared between the two arms and analyzed in the non-randomized SBRT cohort.
Time frame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment