Primary localized high-grade osteosarcoma of extremities, ribs, and sternum in the pediatric and AYA osteosarcoma in pediatric and AYA
Conditions
Interventions
Neoadjuvant and adjuvant chemotherapy regimen (MTP therapy) comprising three drugs (methotrexate [M], pirarubicin [THP-Adriamycin, THP, T], and cisplatin [CDDP, P]) and surgery.
pediatric, AYA, pirarubicin
Sponsors
Arakawa Ayumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with high-grade osteosarcoma based on the images of the primary tumor and the histopathological diagnosis of the tumor material obtained via biopsy. The histological classification should be according to the 4th edition of the Japanese Code of Medical Practice for Malignant Bone Tumors. Regardless of when, biopsy should be performed prior to registration. However, if biopsy was performed in another hospital, the pathological diagnosis must be made by a pathologist at the medical institution where the clinical trial is conducted by ordering a pathological specimen. 2) Patients with a primary lesion located in the upper limb including the upper limb girdle, the lower limb including the lower limb girdle, the sternum, and the ribs. However, patients with primary lesions in the lower limb girdle extending beyond the sacroiliac joint to the sacrum are not eligible. 3) Patients with resectable primary lesion 4) Patients with lesions classified as clinical stage IIA, IIB, or III according to the 8th edition of the Union for International Cancer Control TNM classification. For patients with a primary lesion located in the pelvic region, clinical staging should be conducted in accordance with the 7th edition. 5) Patients aged = 3,000/mm3 (2) Neutrophil count >= 1,500/mm3 (3) Platelet count >= 100,000/mm3 (4) Hemoglobin level >= 8.0 g/dL (5) AST level = 70 mL/min 11) Patients with normal results on the most recent 12-lead resting ECG performed within 28 days of enrollment (the same day of the week 4 weeks prior to enrollment is acceptable) or those without grade 2 or higher abnormality based on the Common Terminology Criteria for Adverse Events version 5.0. 12) Patients with a left ventricular ejection fraction (LVEF) of >= 60% on the last transthoracic echocardiogram conducted within 28 days prior to enrollment (same day of the week 4 weeks prior to enrollment is acceptable). 13) Written informed consent to participate in the study is obtained from patients aged >=16 years. If the patient is a minor aged >=16 years, written informed consent is obtained from the patients and their surrogates.
Exclusion criteria
Exclusion criteria: 1) Patients with complex diabetes mellitus that is being treated with continuous insulin use or those with poorly controlled glucose levels (HbA1c level >= 6.5%) 2) Patients with uncontrolled hypertension 3) Patients with a history of myocardial infarction or unstable angina pectoris 4) Patients with a cardiac pacemaker 5) Patients with an infectious disease requiring systemic treatment 6) Patients with fever (> 38 degrees Celsius, not including tumor fever that can be ruled out as infection) 7) Patients with multiple active cancers (synchronous multiple cancers and iatrogenic multiple cancers with a disease-free interval of <= 5 years). However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that can be cured with local treatment are not classified as active multiple cancers. 8) Pregnant, potentially pregnant, or lactating women 9) Patients with psychiatric disorders or psychiatric symptoms that could interfere with participation in this study 10) Patients receiving continuous systemic administration of steroids (oral or intravenous) 11) Patients who tested positive for HBs antigen, HBc antibody, or HBs antibody. However, they may be enrolled if only HBs antibody is present and there is a documented history of hepatitis B vaccination or the HBV-DNA quantification is less than the detection sensitivity) 12) Patients who tested positive for HIV antibody, HTLV-1 antibody, or HCV antibody. Patients with positive HCV antibodies but without detectable HCV-RNA should be excluded. All of these must be confirmed via blood test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-Year disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-Year relapse-free survival 3-Year overall survival Ratio of standard responders Presurgical progression ratio 3-Year disease-free survival rate in each histological response group Incidence rate of drug-induced cardiac dysfunction Treatment-related mortality rate Incidence rate of other adverse events | — |
Contacts
Public ContactBunpei Miyazaki
National Cancer Center Hospital
Outcome results
None listed