trialsTrialCompleted

COG AREN0532

aka AREN0532

AREN0532 tested treating the lowest-risk Wilms tumours with surgery alone and no chemotherapy, and giving more treatment only to children whose tumours carried particular chromosome losses; both ideas worked and now guide how much therapy each child gets.

AREN0532 was the Children's Oncology Group's risk-stratified trial for favourable-histology Wilms tumour, enrolling 808 children. Those under two years with small stage I tumours (very low risk) had nephrectomy alone and were watched; the standard-risk groups received vincristine and dactinomycin, with doxorubicin and radiotherapy added by stage, and those whose tumours showed loss of heterozygosity at both 1p and 16q, a marker of relapse identified in NWTS-5, were moved to more intensive regimens.

Surgery alone gave excellent survival in the very low-risk group, with the few relapses salvaged, and augmenting therapy for the 1p/16q loss group improved event-free survival compared with historical controls. The trial embedded molecular risk markers in Wilms tumour treatment for the first time.

Setting

Very low-risk and standard-risk favourable-histology Wilms tumour: nephrectomy alone with observation for very low-risk disease, and risk-adapted vincristine, dactinomycin and doxorubicin with or without radiotherapy for the rest, with treatment intensified for tumours with loss of heterozygosity at 1p and 16q

Phase

Phase 3

Sponsor

Children's Oncology Group

Registry

NCT00352534

Headline result

Nephrectomy alone was adequate for very low-risk favourable-histology Wilms tumour, and intensified therapy improved outcomes for tumours with 1p and 16q loss of heterozygosity.

Reported

2018

Enrolled

808