NCT06467097RecruitingPhase 3
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
A Phase Ⅲ Randomized Study Systemic Treatment Alone Versus Systemic Treatment Plus Stereotactic Abative Body Radiotherapy for Patients With Oligometastatic Renal Cell Carcinoma: SABLOR Study
Source: ClinicalTrials.gov · Last updated 20 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 11 Jun 2024
- Start date
- 16 Apr 2024
- Primary completion date
- 13 Feb 2031
- Lead sponsor
- Samsung Medical Center
- Diseases
- Kidney cancer
- NCT number
- NCT06467097
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 88
- From 16 Apr 2024 to the primary completion date, 13 Feb 2031
- 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
- Patients unable to maintain position for partial nephrectomy radiotherapy.
Other illness
- Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
Lab values
- Patients with total bilirubin \> 3.6 mg/dL.
- Patients with AST \>160 U/L, ALT \> 165 U/L.
Other
- Patients with confirmed brain, peritoneal, or pleural metastases.
- Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
- Patients who do not consent to participate in the study.
- Pregnant patients.
Who the study is looking for
- Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases.
- Patients aged 20 to 80 years.
- Patients with individual metastases ≤ 5 cm in longest diameter.
- Patients with primary tumors surgically removed or scheduled for surgery.
- Patients histologically diagnosed with clear cell carcinoma.
- Patients with ECOG performance status 0-1.
- Patients with normal major organ function and bone marrow function meeting specific criteria: WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL.
- Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
- Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
- Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
- Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.
Age in the registry: 20 years to 80 years · 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 |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.