Comparing two chemotherapy regimens for children with advanced kidney tumors
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)
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 |
| Enrollment | 110 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 1 site (Marseille) |
| Trial ID | NCT03669783 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with metastatic renal tumors at initial diagnosis, confirmed by central review.
Not a fit: Patients without confirmed metastatic disease or those with localized tumors may not benefit from this study.
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 performed: Previous studies have shown promising results with similar chemotherapy regimens, but this specific comparison is novel.
Eligibility criteria
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 this trial is running
Marseille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.