NCT03696277CompletedPhase 2
SAbR For Oligo-Progressive Renal Cell Cancer.
A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
Source: ClinicalTrials.gov · Last updated 17 Jul 2024
Brief summary (registry, in English)
Metastatic kidney cancer patients on systemic therapy often develop resistance to limited sites that leads to changing of the systemic therapy. Local therapy to the sites of progression may allow patients to continue on the same systemic therapy that is otherwise effective and being tolerated well. Hypothesis: Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS). Primary Objectives: • To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer). Secondary Objectives: • To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for mRCC patients and its impact on quality of life.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 28 Sept 2018
- Start date
- 1 Oct 2018
- Primary completion date
- 23 Jan 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Kidney cancer
- NCT number
- NCT03696277
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 21
- From 1 Oct 2018 to the primary completion date, 23 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.
Other illness
- Subjects with history of or new brain metastasis.
Other
- Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
Who the study is looking for
- Pathology proven renal cell carcinoma and radiographic confirmation of metastatic renal cell carcinoma
- Patients must have drug responsive RCC as determined by treating medical or radiation oncologist after at least one set of scans.
- Must be on systemic therapy with radiographic scans to verify olio-progression of ≤3 sites and ≤ 30% of all sites.
- Any FDA approved systemic therapy for RCC is allowed. Currently these include small molecule tyrosine kinase inhibitors (TKIs) targeting the vascular endothelial growth factor (VEGF) pathway (sunitinib, pazopanib, cabozantinib, axitinib, sorafenib), monoclonal antibody targeting the same pathway (bevacizumab), the mammalian target of rapamycin pathway (temsirolimus, everolimus), Immune checkpoint inhibitors (Nivolumab and Nivolumab concurrent with Ipilimumab, Lenvatinib in combination with everolimus and nivolumab).
- Must be at least 18 years old
- ECOG 0-2; or KPS \> 60
- Currently receiving 1st - 4th line of systemic therapy
- Any of the above listed systemic therapy is allowed as long as they are being used in the 1st-4th line setting.
- Ability to understand and the willingness to sign a written informed consent.
- Acceptable tolerability of ongoing therapy as decided by the treating medical oncologist
- Patient must have a desire to continue ongoing therapy
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. 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, marital status, 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
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.