Stereotactic Body Radiation Therapy in Treating Patients with Metastatic or Recurrent Kidney Cancer
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 body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
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
- Life expectancy of >= 3 months
- 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; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02542202.
PRIMARY OBJECTIVE:
I. To establish that patients can be treated with 5-fraction stereotactic body radiation therapy (SBRT) to all sites of metastatic disease with a low (< 16%) rate of severe (grade 4) toxicity.
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of SBRT.
II. To determine the feasibility of delivering 5-fraction SBRT per protocol based on proposed normal tissue constraints in a variety of organ sites. (i.e., the ability to treat > 80% of enrolled patients according to protocol guidelines).
III. To describe treated lesion control (LeC), progression free survival (PFS), and patterns of failure.
IV. To determine the feasibility of accrual and adequacy of eligibility criteria by defining the proportion of eligible cases of metastatic renal cell carcinoma (RCC) presented at the weekly multidisciplinary genitourinary conference at the University of Chicago Medical Center.
V. To make a preliminary evaluation regarding potential biomarkers in patient serum which may be endpoints in a follow-up study (e.g. genetic or immunologic biomarkers).
OUTLINE:
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.
After completion of study treatment, patients are followed up once a month for 3 months and then every 3 months for 1 year.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorStanley Lawrence Liauw
- Primary IDIRB14-1542
- Secondary IDsNCI-2015-01322
- ClinicalTrials.gov IDNCT02542202