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

University of Michigan Rogel Cancer Center

Status: Terminated

Conditions: Renal Cell Carcinoma

Treatments: Radiation: RFA; Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02138578

HUM00076618 (Other Identifier)

UMCC 2013.069

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Randomized SBRT

Experimental group

Description:

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.

Treatment:

Radiation: SBRT

Randomized RFA

Active Comparator group

Description:

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.

Treatment:

Radiation: RFA

Non-Randomized SBRT

Active Comparator group

Description:

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.

Treatment:

Radiation: SBRT