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

This is an interventional treatment trial for Metastatic Renal Cell Cancer Read More

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
• Age 18 years or older
• Life expectancy of >= 3 months

• Patients must have normal organ and marrow function within 30 days of registration, as defined below:

  • Absolute neutrophil count >= 500/mcL
  • Hemoglobin >= 8.0 g/dL
  • Platelets >= 50,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal if liver metastases are present
• Women of childbearing potential must have a negative pregnancy test within 14 days of registration
• Patients must have the ability to understand and the willingness to sign a written informed consent document

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;
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration;
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease if the liver is involved with metastatic disease;
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
• Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment