Stereotactic Body Radiation Therapy in Treating Patients With Oligometastatic Renal Cell Carcinoma

Prior treatment

• Receipt of > 1 line of systemic therapy directed towards the metastatic disease. This exclusion criteria will not apply for Cohort B, including the modified Cohort B definition
  • Systemic therapy as a component of prior definitive therapy directed towards non-metastatic disease will be allowed. For example, patients receiving adjuvant interleukin (IL)-2 after nephrectomy for an initial M0 diagnosis and who subsequently developed metastatic relapse will be allowed on study. In this instance, there will be no mandatory wash-out period required for enrollment.
  • At trial entry the patient must have received their last dose of systemic therapy (e.g. last intravenously [IV] administration of orally [PO] tablet/pill) 4 weeks prior to initiation of the first dose of radiation

Other illness

• Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team.
• Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion of the treating physician cannot be treated definitively.

Lab values

• Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation.
  • Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Other

• Metastatic effusion (e.g. pleural effusion or ascites). Note that patients with an effusion that is too small to sample will be eligible for the trial.

• Pathologically confirmed diagnosis of RCC of any histology.
• Be willing and able to undergo biopsy of a lesion planned for definitive RT (such as SBRT) both post treatment and pretreatment. If a lesion amenable to definitive RT was biopsied prior to enrollment, this material can be used in lieu of a planned biopsy if the tissue is available for review and ki-67 staining at MD Anderson.
  • Patients may be allowed on this trial without a biopsy if they are deemed medically unfit for biopsy or if the biopsy poses undue risk in the opinion of the treating physician(s).
• Be >= 18 years of age on the day of signing informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status.
• COHORT A: Oligometastatic RCC patients (=< 5 metastatic lesions at the time of study entry).
• COHORT B: Patients eligible for Cohort A in addition to low volume metastatic patients. Low volume metastatic patients are defined as those with > 5 metastatic lesions, but with =< 5 metastatic lesions when excluding lesions < 1 cm short axis and LNs < 1 cm short axis
• Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians
• Absolute neutrophil count (ANC) >= 1,000 /mcL (within 6 weeks prior to study enrollment).
• Platelets >= 50,000 / mcL (within 6 weeks prior to study enrollment).
• Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (within 6 weeks prior to study enrollment).
• Serum total bilirubin =< 1.5 mg//dl (except for subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 mg/dl (within 6 weeks prior to study enrollment).
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 X upper limit of normal ULN OR =< 5 X ULN for subjects with liver metastases (within 6 weeks prior to study enrollment).
• At least one site which in the opinion of the treating radiation oncologist is treatable with definitive RT and can be biopsied