Chemotherapy consists of Adriamycin and Ifosfamide for the patients with high grade primary bone sarcoma except for Ewing sarcoma over 41, Phase II trial

Chemotherapy consists of Adriamycin and Ifosfamide for the patients with high grade primary bone sarcoma except for Ewing sarcoma over 41, Phase II trial - AI for bone sarcomas over 41-PII

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015982

Enrollment

Registered

2015-01-10

Start date

2015-01-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with high grade primary bone sarcoma except for Ewing sarcoma over 41

Interventions

Three courses of preoperative chemotherapy with adriamycin (30mg/m2/day, day 1-2) and ifosphamide (2g/m2/day, day 1-5) every three weeks followed by surgical resection and three courses of postperativ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Untreated case with a histological diagnosis of grade 2 or 3 (FNCLCC histological grading system) primary bone sarcoma except for Ewing sarcoma aged over 41 using open biopsy specimen. 2. 10 or more unstained tumor tissue slides are available 3. Resectable tumor 4. Measurable lesion on MRI axial section 5. ECOG performance status 0 or 1 6. Age between 20 and 70 years 7. No metastasis 8. Sufficient organ function with following condition; 1)Neutrophil count>1500/mm3 2)Platelet count>10x104/mm3 3)Hemoglobin>8.0g/dl 4)Alanine aminotransferase, Asparate aminotransferase <2.5 ULN (upper limit of normal) 5)Blood Bilirubin<1.5mg/dl 6)Creatinine<1.5mg/dl 7)CCr>60ml/min 8)No abnormal ECG findings 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1) Severe comorbid illness 2) Active infection 3) Synchronous or metachronous (within 5 years) malignancies 4) History of chemotherapy using ADR and/or IFO 5) Poorly renal or bladder function 6) Severe myelosuppression 7) Abnormal heart function 8) Patients having a pacemaker 9) Patients requiring pentostatin 10) Women in pregnant, possibly pregnant or breast feeding 11) Patients requiring systemic steroid medication 12) Psychiatric disease 13) Positive HBs antigen, HBs antibody, or HBc antibody

Design outcomes

Primary

Measure	Time frame
3-year progression- free survival	—

Secondary

Measure	Time frame
Proportion of completion of preoperative chemotherapy without progression disease, 5-year progression- free survival, progression- free survival, overall survival, disease progression rate, preoperative progression rate, adverse event, postoperative complication rate, the ratio of the patients who were performed limb sparing surgery, function of postoperative limb	—

Countries

Japan

Contacts

Public ContactAkihito Nagano

Gifu University school of medicine The department of Orthopaedic surgery

a-nagano@lucky.odn.ne.jp058-230-6333

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026