Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02138578|
Recruitment Status : Terminated (Due to changes in scanning procedure, and infeasible biopsy and baseline imaging, the trial closed for poor accrual and inability to follow patients.)
First Posted : May 14, 2014
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Radiation: SBRT Radiation: RFA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for the Treatment of Localized Renal Cell Carcinoma (RCC)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2017|
Experimental: Randomized SBRT
Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.
Other Name: Stereotactic Body Radiation Therapy
Active Comparator: Randomized RFA
Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.
Other Name: Radiofrequency Ablation
Active Comparator: Non-Randomized SBRT
Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.
Other Name: Stereotactic Body Radiation Therapy
- Proportion of Patients With Local Control of Disease [ Time Frame: 12 months ]On imaging, local control will be defined as when the treated lesion shows no enhancement.
- Cumulative Incidence of Grade 2 and Greater Toxicities [ Time Frame: up to 30 days after the last study treatment ]The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).
- Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms [ Time Frame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment ]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.
- Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms [ Time Frame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment ]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.
- Metastasis Free Survival Time [ Time Frame: 36 months post treatment ]
- Overall Survival Time [ Time Frame: 36 months post treatment ]
- Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms [ Time Frame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138578
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Daniel Spratt, M.D.||University of Michigan Rogel Cancer Center|