At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed Stage IV favorable histology Wilms tumor with or without LOH 1p and 16q
- ✓Newly diagnosed Stage III favorable histology Wilms tumor with LOH for 1p and 16q transferring from AREN0532
- ✓Less than 30 years of age at diagnosis
- ✓Karnofsky performance status ≥50 (age >16) or Lansky performance status ≥50 (age ≤16)
- ✕Bilateral Wilms tumors (Stage V)
- ✕Prior tumor-directed chemotherapy or radiotherapy (except transfers from AREN0532 or emergent treatments)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
In Brief
A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Conventional Surgery, and 5 other interventions for Stage III Kidney Wilms Tumor and Stage IV Kidney Wilms Tumor. Completed, enrolled 395 participants across 227 sites in 7 countries.
Signals
Detailed Summary
This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
Study Details
Timeline
Arms & Interventions
REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy. Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M. REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; vincristine IV; and dactinomycin IV and doxorubicin hydrochloride IV. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy.
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV