sabr for oligometastatic renal cell carcinoma

Conditions: Oligometastatic Renal Cell Carcinoma

Summary: hypothesis: stereotactic ablative body radiation (sabr) prolongs progression-free survival for patients with oligometastatic kidney cancer (rcc) and delays the initiation of systemic therapy. primary objectives: • to evaluate the delay in time to start of systemic therapy (ttst) as a surrogate of progression free survival (pfs), defined as the time from the first day of sabr to start of systemic therapy. secondary objective: * to evaluate the modified progression-free survival (mpfs) for patients with oligometastatic renal cell carcinoma who are treated with sabr. * to evaluate the overall survival (os) * to evaluate the cancer specific survival (css) * to evaluate the local control rate of irradiated lesions. * to measure the health-related quality of life (hrqol).

the study is a prospective single institution phase ii single-arm open-label trial evaluating sabr in patients with newly diagnosed oligometastatic rcc. problem statements: * can local therapy (sabr) safely delay the start of systemic therapy? * safely delaying the start of systemic therapy can have significant quality of life benefits for patients since systemic therapy has significant side effects. * can sabr be curative in truly oligometastatic rcc patients? primary endpoint: • time to start of systemic therapy (ttst) defined as the time from the first day of sabr to start of systemic therapy. secondary endpoint: * modified progression-free survival (mpfs) is defined as the survival interval without development of \>3 sites of new metastasis, new sites of metastases that are not amenable to sabr treatment, a total of \>6 sites of metastasis that required sabr, local failure at sabr-treated site, or development of brain metastasis. * overall survival * local control * toxicity * hrqol sample size: 23 patients will be enrolled. statistical analysis: time to event will be estimated using the kaplan-meier approach along with the 95% confidence interval.

Eligibility criteria:
inclusion criteria: * metastatic renal cell carcinoma with limited measurable extracranial metastases (limited metastases, or oligometastases, defined as ≤3 sites of metastasis). * radiographic evidence of metastatic disease. ct should be performed within 30 days of registration. * pathology confirmation of renal cell carcinoma. * prior surgery, or radiation is permitted. * age ≥ 18 years. * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and for 90 days after radiation treatment has been completed . should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * ability to understand and the willingness to sign a written informed consent and agrees to undergo image studies and follow up exclusion criteria: * subjects with brain metastasis as assessed by contrast mri or contrast ct scans(contrast recommended). * subjects with previous history of brain metastasis. * subjects that received prior systemic therapy for kidney cancer in the past 1 year, except one line of immuno- or cytokine therapy (e.g. prior il-2); systemic therapy for other cancers does not apply to this exclusion criteria * subjects with ≥3 unfavorable prognostic factors defined by motzer et al. (1999), (kps \ 1, hgb \ 1.5x normal, corrected serum calcium \>10mg/dl and absence of prior nephrectomy), patients with 0, 1-2, and ≥3 factors had time to death of 20 months, 10 months and 4 months. * subjects with life expectancy \< 6 months. * subjects receiving any other investigational agents * subjects must not be pregnant due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Keywords: renal cell, stereotactic ablative body radiotherapy (sabr), pazopanib, oligo-mets