Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for Renal Cell Carcinoma

Not Applicable

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Radiation: SBRT; Radiation: RFA

• Registration Number: NCT02138578
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-16
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Status Verified: 2017-10
• Results First Submitted: 2017-10-11
• Results First Submitted QC: 2017-10-11
• Last Update Submitted: 2017-10-11
• Results First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients younger than 18 or pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Randomized SBRT	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.
Randomized RFA	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.
Randomized SBRT	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.

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Grade 2 and Greater Toxicities	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).
Proportion of Patients With Local Control of Disease	12 months	On imaging, local control will be defined as when the treated lesion shows no enhancement.

Secondary Outcome Measures

Name	Time	Method
Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms	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.
Metastasis Free Survival Time	36 months post treatment
Overall Survival Time	36 months post treatment
Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms	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.
Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States