NCT02956798Completed
SAbR For Oligometastatic Renal Cell Carcinoma
Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 26 Oct 2016
- Start date
- 19 Jul 2018
- Primary completion date
- 24 Jan 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Kidney cancer
- NCT number
- NCT02956798
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 19 Jul 2018 to the primary completion date, 24 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.