SAbR For Oligometastatic Renal Cell Carcinoma

Korábbi kezelés

• 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 receiving any other investigational agents

Laborértékek

• Subjects with ≥3 unfavorable prognostic factors defined by Motzer et al. (1999), (KPS <80% or ECOG>1, Hgb < LLN, LDH >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.

Egyéb

• Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans(contrast recommended).
• Subjects with life expectancy < 6 months.
• Subjects must not be pregnant due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

• 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