Trial Outcomes & Findings for Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for Renal Cell Carcinoma (NCT NCT02138578)

Results Overview

On imaging, local control will be defined as when the treated lesion shows no enhancement.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

12 months

Results posted on

2017-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized 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. SBRT	Non-Randomized 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. SBRT
Overall Study STARTED	1	3
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized SBRT n=1 Participants 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. SBRT	Randomized 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. RFA	Non-Randomized SBRT n=3 Participants 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. SBRT	Total n=4 Participants Total of all reporting groups
Age, Continuous	87 years n=5 Participants	—	66 years n=5 Participants	71.25 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	1 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	2 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).

On imaging, local control will be defined as when the treated lesion shows no enhancement.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 30 days after the last study treatment

Population: Although no patients reported toxicity, the trial had poor accrual and patients were unable to be followed per protocol.

The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).

Outcome measures

Outcome measures
Measure	Randomized SBRT n=1 Participants 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. SBRT	Randomized 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. RFA	Non-Randomized SBRT n=3 Participants 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. SBRT
Cumulative Incidence of Grade 2 and Greater Toxicities	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment

Population: Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment

Population: Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months post treatment

Population: Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months post treatment

Population: Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment

Population: Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).

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.

Outcome measures

Outcome data not reported

Adverse Events

Randomized SBRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized RFA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Randomized SBRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Spratt, M.D.

University of Michigan Comprehensive Cancer Center

Phone: 734-936-4300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place