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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02138578
• Other study ID #: UMCC 2013.069
• Secondary ID: HUM00076618
• Status: Terminated
• Phase: N/A
• First received: April 16, 2014
• Last updated: October 11, 2017
• Start date: May 2014
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Radiation:
• SBRT

• RFA

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Local Control of Disease	On imaging, local control will be defined as when the treated lesion shows no enhancement.	12 months
Primary	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).	up to 30 days after the last study treatment
Secondary	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.	Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
Secondary	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.	Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment
Secondary	Metastasis Free Survival Time		36 months post treatment
Secondary	Overall Survival Time		36 months post treatment
Secondary	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.	Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment