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Completed NCT02956798

SAbR For Oligometastatic Renal Cell Carcinoma

Conditions: Oligometastatic Renal Cell Carcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 23
Sponsor: University of Texas Southwestern Medical Center

Location: University of Texas Southwestern Medical Center Dallas Texas

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).

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 \< 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. * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02956798). StuddyBuddy aggregates publicly available trial information.