Comparing two chemotherapy regimens for children with advanced kidney tumors
Official title: Randomized Open-label Non-inferiority Phase 3 Clinical Trial for Patients With a Stage IV Childhood Renal Tumor, Comparing Upfront Vincristine, Actinomycin-D and Doxorubicin (Standard Arm) With Upfront Vincristine, Carboplatin and Etoposide (Experimental Arm)
Run by Assistance Publique Hopitaux De Marseille · NCT03669783 · Data updated 2026-11-12
This study is testing if a new combination of chemotherapy drugs can help children with advanced kidney tumors do better than the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | February 3, 2023 |
| Main results expected | October 3, 2028 |
| Study ends | October 3, 2033 |
| Registry record updated | April 8, 2025 |
| Trial ID | NCT03669783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children diagnosed with metastatic renal tumors at initial diagnosis, confirmed by central review.
✕Probably not a fit
Patients without confirmed metastatic disease or those with localized tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different chemotherapy regimens for children diagnosed with stage IV nephroblastoma, a type of kidney cancer. The standard treatment involves a combination of vincristine, actinomycin-D, and doxorubicin, while the experimental arm tests a regimen of vincristine, carboplatin, and etoposide. Patients will receive neoadjuvant chemotherapy before surgery, followed by risk-based adjuvant treatment. The study seeks to determine if the experimental regimen can improve outcomes for patients with metastatic disease.
Why it matters
Potential benefit: If successful, this trial could lead to improved survival rates and treatment options for children with advanced kidney tumors.
How similar studies have gone: Previous studies have shown promising results with similar chemotherapy regimens, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * suffering from metastatic renal tumour at initial diagnosis * having at least one circumscript, non-calcified (pulmonary) nodule (or other lesion highly suspicious of metastasis according to criteria for metastatic disease) ≥ 3 mm as determined by chest CT-scan and abdominal CT-scan/MRI. * Metastatic disease must be confirmed by central review. Exclusion Criteria: \-
Where it's running
-
Assistance Publique Hopitaux de Marseille
Marseille, France Recruiting
Study contacts
- Study coordinator: Arnauld VERSCHUUR
- Email: arnauld.verschuur@ap-hm.fr
- Phone: +33.491.38.84.78
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.