Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Metastatic or Recurrent Kidney Cancer (NCT NCT02542202)

Last Updated: 2024-05-30

Results Overview

RT-related grade \>= 4 toxicity will be determined on a case-by-case basis by the study group, taking into consideration the region treated with SBRT, timing of the toxicity, and the nature of the toxicity. Rates of RT-related grade \>= 4 toxicity will be recorded, time to RT-related grade \>= 4 toxicity will be recorded, and freedom from RT-related grade \>= 4 toxicity will be determined using the Kaplan-Meier method.

Recruitment status

TERMINATED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiation Therapy Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo stereotactic body radiation therapy
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Body Radiation Therapy n=15 Participants Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo stereotactic body radiation therapy
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	11 Participants n=99 Participants
Age, Continuous	67.9 years STANDARD_DEVIATION 10.5 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	12 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants
Number of Baseline Lesions	1 number of lesions n=99 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy n=15 Participants Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo stereotactic body radiation therapy
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Skin	0 participants
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Nausea	0 participants
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Gastrointestinal	0 participants
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Genitourinary	0 participants
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Respiratory	0 participants
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Neurology	0 participants
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity Total	0 participants

SECONDARY outcome

Timeframe: From the start of treatment to the time of local progression at each treated lesion, assessed up to 1 year

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy n=15 Participants Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo stereotactic body radiation therapy
Treated Lesion Control (LeC)	1 Participants

SECONDARY outcome

Timeframe: From start of treatment to time of progression, assessed up to 1 year

Progression-free survival is defined as defined as progression in the treated lesion, organ in which the treated lesion is present, distant failure, or death from any cause any new sites of disease on imaging or any progressive disease by RECIST criteria at initially treated sites of disease (within 80% isodose line). PFS will be estimated using descriptive statistics and the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy n=15 Participants Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo stereotactic body radiation therapy
Progression-free Survival	46 percentage of total Interval 20.0 to 68.0

SECONDARY outcome

Timeframe: Up to 1 year

Toxicities of interest that occur within the 3-12 month time frame after RT start will be documented and analyzed using descriptive statistics and the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy n=15 Participants Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo stereotactic body radiation therapy
Toxicity Profile of 5-fraction SBRT Based on Normal Tissue Dosimetric Constraints Based on the Organ Site of Involvement	85 percentage of total Interval 53.0 to 96.0

Adverse Events

Stereotactic Body Radiation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rohan Katipally

UChicago

Phone: 773-702-0137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place