Clinical trial Recruiting at 1 site Phase 3 Interventional Ages Any age to 17

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

PhasePhase 3
Study typeInterventional
AgesAny age to 17 Years
SexAll
Enrollment110 (estimated)
SponsorAssistance Publique Hopitaux De Marseille
Academic / other
Drugs / interventionschemotherapy, radiation, doxorubicin
Locations1 site (Marseille)
StatusRecruiting
StartedFebruary 3, 2023
Main results expectedOctober 3, 2028
Study endsOctober 3, 2033
Registry record updatedApril 8, 2025
Trial IDNCT03669783 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:

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Where it's running

  • Assistance Publique Hopitaux de Marseille
    Marseille, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.