A Pilot Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Renal Cell Carcinoma

University of Chicago1 site in 1 country25 target enrollmentMay 1, 2015

ConditionsMetastatic Renal Cell Cancer Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Metastatic Renal Cell Cancer
Sponsor: University of Chicago
Enrollment: 25
Locations: 1
Primary Endpoint: Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot clinical trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with kidney cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

Registry

clinicaltrials.gov

Start Date

May 1, 2015

End Date

March 23, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have histologically or cytologically confirmed metastatic or recurrent RCC (any histologic subtype)
•Patients must have between 1 to 5 new or recurrent lesions suspicious for metastatic RCC on diagnostic imaging
•Each extracranial lesion must be =\< 6 cm and amenable to SBRT or surgical excision
•Patients must have 3 or fewer brain metastases, of size =\< 4 cm
•Brain metastases must be treated prior to enrollment in the study; the modality of treatment of brain metastases can include surgical resection, whole brain radiotherapy, stereotactic radiosurgery, or any combination of the above
•Patients who have an intact unresected primary tumor should be considered for radical nephrectomy and primary resection prior to enrollment in the study; if the patient is not eligible for surgical resection, the primary tumor must be amenable to SBRT or request for applications (RFA); generally, this will be defined as a primary tumor \< 10 cm in size or a primary lesion which can be treated to a dose of \>= 8 Gy x 5 without excessive perceived risk of toxicity
•Patients must have had at least a computed tomography (CT) of the chest, abdomen, and pelvis within 4 weeks of registration in the trial; CT or magnetic resonance imaging (MRI) of the brain is only required in the presence of neurologic symptoms
•Patients must have had no radiotherapy, immunotherapy, chemotherapy or therapy with targeted agents within the last 1 month
•Patients may not have had prior bevacizumab, based on case reports of tracheoesophageal fistula in patients treated with bevacizumab and radiotherapy
•Eastern Cooperative Oncology Group (ECOG) performance status =\<2

Exclusion Criteria

•Patients who have had prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy within 1 month of enrollment
•Patients who have had any prior bevacizumab, due to case reports suggesting a possible risk of severe toxicity in combination with radiotherapy
•Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy
•Patients may not be receiving any systemic anti-cancer agents or other investigational agents during radiation therapy
•Patients may not have received prior radiation therapy to a site of recurrence which would require overlap of appreciable radiation dose
•Known active invasive malignancy except for renal cell carcinoma and/or non-melanoma skin cancer
•Severe, active co-morbidity, defined as follows:
•Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration;
•Transmural myocardial infarction within the last 6 months prior to registration;
•Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;

Outcomes

Primary Outcomes

Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity

Time Frame: Up to 1 year

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.

Secondary Outcomes

Progression-free Survival(From start of treatment to time of progression, assessed up to 1 year)
Toxicity Profile of 5-fraction SBRT Based on Normal Tissue Dosimetric Constraints Based on the Organ Site of Involvement(Up to 1 year)
Treated Lesion Control (LeC)(From the start of treatment to the time of local progression at each treated lesion, assessed up to 1 year)