Clinical trial NCT02138578: Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for Renal Cell Carcinoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria for SBRT vs. RFA Randomization:

* Patients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA (Renal cell carcinoma must be pathologically proven).
* The primary tumor must be in a location amendable to RFA within the kidney.
* Patients must be appropriate candidates for RFA, with platelets ≥50,000/mm3 and an international normalized ratio of 1.5.
* Patients must have an ECOG (a measurement of general well being and activities of daily living; scores range from 0 to 5 where 0 represents perfect health) score ≤ 3.
* There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
* Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
* Ability to understand and the willingness to sign a written informed consent.
* If a patient is randomized to the RFA arm, but is deemed not to be an anesthesia candidate, he/she will be placed in the non-randomized SBRT cohort.

Inclusion Criteria for non-randomized SBRT arm:

* Patients with renal cell carcinoma less than 8 cm in maximum diameter, patients with metastatic RCC who require local palliation or are progressing through systemic disease, patients who are poor surgical candidates and have tumor location not amenable to RFA, or patients who would prefer a noninvasive means of treatment are eligible for the non-randomized SBRT cohort (Renal cell carcinoma must be pathologically proven).
* There are no limitations based on location of the primary tumor within the kidney.
* Patients must have an ECOG score ≤ 3.
* There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
* Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients younger than 18 or pregnant women.

Primary outcomes:
measure: Proportion of Patients With Local Control of Disease
timeFrame: 12 months
measure: Cumulative Incidence of Grade 2 and Greater Toxicities
timeFrame: up to 30 days after the last study treatment
Secondary outcomes:
measure: Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms
timeFrame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
measure: Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms
timeFrame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
measure: Metastasis Free Survival Time
timeFrame: 36 months post treatment
measure: Overall Survival Time
timeFrame: 36 months post treatment
measure: Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms
timeFrame: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Daniel Spratt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: