# SIOPEL-3

Source: https://onco.cc/trials/siopel-3/  
OnCo record `siopel-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

SIOPEL-3 showed that children with standard-risk hepatoblastoma can be cured with cisplatin alone before and after surgery, leaving out doxorubicin and its heart damage, because the cure rate was the same as with the two-drug combination.

## Summary

SIOPEL-3 was the international liver tumour trial of the SIOP group. Children with standard-risk hepatoblastoma were randomised to cisplatin alone or to cisplatin plus doxorubicin, given as pre-operative chemotherapy with delayed resection and continued after surgery; the primary endpoint was the complete resection rate, with survival and toxicity as secondary endpoints. A separate high-risk stratum received intensified therapy.

Complete resection was achieved in 95 percent of the cisplatin group and 93 percent of the combination group; three-year event-free survival was 83 against 85 percent and overall survival 95 against 93 percent, while grade 3 or 4 acute toxicity was far more frequent with the combination (74.4 against 20.6 percent). Cisplatin monotherapy with delayed resection is the standard for standard-risk hepatoblastoma on the corpus's hepatoblastoma page, with sodium thiosulfate added after each dose to protect hearing following SIOPEL-6.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: SIOPEL 3; SIOPEL3; SIOP-SIOPEL-3
- Tags: soc-trials
- Registry id: NCT00003912
- Phase: 3
- Setting: Standard-risk hepatoblastoma in children (tumour confined to the liver, no more than three sectors involved, no metastases): pre-operative cisplatin alone against cisplatin plus doxorubicin (PLADO), with delayed resection and post-operative chemotherapy
- Sponsor: Societe Internationale d'Oncologie Pediatrique
- Enrolled: 255
- Result: Complete resection 95 percent with cisplatin alone against 93 percent with cisplatin plus doxorubicin; three-year overall survival 95 against 93 percent; grade 3 or 4 toxicity 20.6 against 74.4 percent.
- Outcomes: Complete resection (intention to treat): Cisplatin alone 95% vs Cisplatin + doxorubicin (PLADO) 93%; Event-free survival at 3 years: Cisplatin alone 83% vs Cisplatin + doxorubicin (PLADO) 85%; Overall survival at 3 years: Cisplatin alone 95% vs Cisplatin + doxorubicin (PLADO) 93%; Acute grade 3 or 4 adverse events: Cisplatin alone 20.6% vs Cisplatin + doxorubicin (PLADO) 74.4%

## Sources

- ClinicalTrials.gov NCT00003912: https://clinicaltrials.gov/study/NCT00003912

## Connected records

- cancers: [Childhood cancers (all types)](https://onco.cc/cancers/childhood-cancers/), [Hepatoblastoma](https://onco.cc/cancers/hepatoblastoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/)
- key papers: [SIOPEL-3: cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma](https://onco.cc/key-papers/paper-siopel-3-cisplatin-vs-plado-standard-risk-hepatoblastoma-perilongo-nejm-2009/)

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