A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for the Treatment of Localized Renal Cell Carcinoma (RCC)

University of Michigan Rogel Cancer Center1 site in 1 country4 target enrollmentMay 2014

ConditionsRenal Cell Carcinoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: University of Michigan Rogel Cancer Center
Enrollment: 4
Locations: 1
Primary Endpoint: Cumulative Incidence of Grade 2 and Greater Toxicities
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

February 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan Rogel Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Patients younger than 18 or pregnant women.

Outcomes

Primary Outcomes

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).

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.

Secondary Outcomes

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)
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)
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)