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New treatment option for Renal Cell Carcinoma (Kidney Cancer)
Official title Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
ClinicalTrials.gov ID: NCT06726421
What this study is testing
What is axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib?
axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal cell carcinoma (kidney cancer).
Also referred to as Standard systemic therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III randomized controlled trial evaluates the efficacy of stereotactic body radiation therapy (SBRT) in oligometastatic renal cell carcinoma. The study aims to determine if the addition of SBRT to standard systemic therapy prolong survival compared to the standard systemic therapy alone.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed diagnosis of renal cell carcinoma of any histology
- Age ≥ 18 years.
- ECOG performance status of 0-2.
- Imaging suggests the presence of distant metastases, with no more than 5 metastatic lesions according to RECIST 1.1 criteria and MDA standards.
- The patient has received local therapy to primary site, including surgery, stereotactic radiotherapy, or ablation.
You likely can't join if
- Presence of intracranial metastases.
- Target lesions have previously received high-dose irradiation with .
- Target lesions are unsuitable for radiation therapy judged by treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or...
- Uncontrollable metastatic pleural effusion or ascites.
- Presence of other malignancies that have not been cured.
- History of significant psychiatric disorders that impede understanding of informed consent and compliance with the study protocol.
See the full eligibility criteria
- Pathologically confirmed diagnosis of renal cell carcinoma of any histology
- Age ≥ 18 years.
- ECOG performance status of 0-2.
- Imaging suggests the presence of distant metastases, with no more than 5 metastatic lesions according to RECIST 1.1 criteria and MDA standards.
- The patient has received local therapy to primary site, including surgery, stereotactic radiotherapy, or ablation.
- The patient has received no more than 2 lines of systemic therapy.
- No significant impairment of major organ function: Hemoglobin (HB) ≥ 80 g/L Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelets (PLT) ≥ 75 × 10⁹/L Serum total bilirubin ≤ 1.5 × ULN Alanine aminotransferase (ALT) and...
- Presence of intracranial metastases.
- Target lesions have previously received high-dose irradiation with .
- Target lesions are unsuitable for radiation therapy judged by treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).
- Uncontrollable metastatic pleural effusion or ascites.
- Presence of other malignancies that have not been cured.
- History of significant psychiatric disorders that impede understanding of informed consent and compliance with the study protocol.
- Presence of other serious illnesses that may pose significant risks or affect radiation therapy.
- Women who are pregnant, breastfeeding, or with plans for childbearing during the study.
- Any other reasons deemed by the investigator to make the subject unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Changchun, Jilin, China
- Chengdu, Sichuan, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Changchun, Jilin, China; Chengdu, Sichuan, China; Wenzhou, Zhejiang, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.