Skip to content
Bending the Curve Trial by Trial
?

JCOG0905

Methotrexate, Doxorubicin, and Cisplatin Versus Methotrexate, Doxorubicin, and Cisplatin + Ifosfamide in Poor Responders to Preoperative Chemotherapy for Newly Diagnosed High-Grade Osteosarcoma (JCOG0905): A Multicenter, Open-Label, Randomized Trial

N = 287

Population
Patients aged 50 years or younger with resectable high-grade osteosarcoma (stage II or III) of the extremities, limb girdles or thoracic wall and a poor response to preoperative MAP
Design
Open-label randomised trial of the Japan Clinical Oncology Group (registered jRCTs031180126; not on ClinicalTrials.gov). After two MAP cycles and tumour resection, patients with a poor response were randomised to MAP or MAP plus ifosfamide (MAPIF). Planned sample size 100 patients, one-sided alpha 0.1, power 0.7. 287 patients registered between February 2010 and August 2020; 51 and 52 poor responders randomised.
Primary endpoint
DFS
Arms
  • MAP (control, n = 51): Methotrexate, doxorubicin and cisplatin
  • MAP plus ifosfamide (MAPIF) (experimental, n = 52): MAP plus ifosfamide, 15 g/m2 (3 g/m2 once daily on days 1-5) x six
People
Hiraga H, Japan Clinical Oncology Group
DFSHR 1.05 (95% CI 0.55–1.98)OSHR 1.48 (95% CI 0.68–3.22)
Show the numbers
Results reported for JCOG0905
EndpointAnalysisMAP plus ifosfamide (MAPIF)MAPEffect
DFSPoor responders randomised (51 MAP, 52 MAPIF)primaryHiraga 2025——HR 1.05 (95% CI 0.55–1.98)MAPIF vs MAP. Nine patients in the MAPIF group and none in the MAP group discontinued treatment because of adverse events.
OSPoor responders randomised (51 MAP, 52 MAPIF)primaryHiraga 2025——HR 1.48 (95% CI 0.68–3.22)MAPIF vs MAP; the abstract describes OS as numerically inferior in the MAPIF group (secondary endpoint).
Results reported for JCOG0905
EndpointAnalysisMAP plus ifosfamide (MAPIF)MAPEffect
DFSPoor responders randomised (51 MAP, 52 MAPIF)primaryHiraga 2025——HR 1.05 (95% CI 0.55–1.98)MAPIF vs MAP. Nine patients in the MAPIF group and none in the MAP group discontinued treatment because of adverse events.
OSPoor responders randomised (51 MAP, 52 MAPIF)primaryHiraga 2025——HR 1.48 (95% CI 0.68–3.22)MAPIF vs MAP; the abstract describes OS as numerically inferior in the MAPIF group (secondary endpoint).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS1.050.55–1.98
OS1.480.68–3.22
Primary publication: Hiraga H, Machida R, Kawai A, Kunisada T, Yonemoto T, Endo M, et al. Methotrexate, Doxorubicin, and Cisplatin Versus Methotrexate, Doxorubicin, and Cisplatin + Ifosfamide in Poor Responders to Preoperative Chemotherapy for Newly Diagnosed High-Grade Osteosarcoma (JCOG0905): A Multicenter, Open-Label, Randomized Trial. J Clin Oncol. 2025;43(16):1886-1897. PubMedDOI

Appears in

Sources

  1. Hiraga H, Machida R, Kawai A, Kunisada T, Yonemoto T, Endo M, et al. Methotrexate, Doxorubicin, and Cisplatin Versus Methotrexate, Doxorubicin, and Cisplatin + Ifosfamide in Poor Responders to Preoperative Chemotherapy for Newly Diagnosed High-Grade Osteosarcoma (JCOG0905): A Multicenter, Open-Label, Randomized Trial. J Clin Oncol. 2025;43(16):1886-1897.

    PubMedDOI