To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.
Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma of pelvis and sacrum have included surgery with adjuvant chemotherapy. Pre-surgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of pre-surgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy, especially in the axial region. The contribution of chemotherapy and surgery timing has not been tested rigorously. To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum, we conducted multicenter randomized trial to determine whether chemotherapy administered before definitive resection of primary tumors improved EFS and overall survival compared with traditional resection of the primary tumor followed by adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
60mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
100mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
High dose of methotrexate (8-12g/m\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall survival (OS)
Calculated from the date of treatment start until death, whichever comes first.
Time frame: 5 years
Progression-free survival (PFS)
Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Time frame: 5 years
Tumor necrosis rate
The percentage of tumor necrosis calculated in the resected specimen in Arm 2.
Time frame: 5 years
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12g/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Including limb-sparing procedure and amputation
chemotherapy that given before definitive surgery