Osteosarcoma of Pelvis
Conditions
Keywords
osteosarcoma, pelvis, sacrum
Brief summary
To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.
Detailed description
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.
Interventions
DRUGDoxorubicin
60mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
DRUGCisplatin
100mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
DRUGMethotrexate
High dose of methotrexate (8-12g/m\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
DRUGIfosfamide
12g/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
PROCEDUREdefinitive surgery
Including limb-sparing procedure and amputation
OTHERpre surgical chemotherapy
chemotherapy that given before definitive surgery
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age \>10 years and \<40 years; * High-grade nonmetastatic osteosarcoma in pelvis or sacrum; * Diagnosis confirmed histologically and reviewed centrally; * No evidence of metastatic disease with computed tomography scan of the chest and radionuclide bone scan, or Positron Emission Tomography (PET/CT) within 2 weeks of entry; * No prior therapy; * Eastern Cooperative Oncology Group performance status 0-1; * Life expectancy \>3 months; * Adequate renal, hepatic, and hemopoietic function;
Exclusion criteria
* Previously treated by chemotherapy or unplanned surgery in other hospital; * Have had other kinds of malignant tumors at the same time; * Uncontrolled complications, such as diabetes mellitus and so on; * Intravascular tumor thrombus on enhanced CT or magnetic resonance (MR); * Unresectable disease evaluated by surgeons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 5 years | Calculated from the date of treatment start until death, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 5 years | Calculated from the date of treatment start until the time of disease progression or death, whichever comes first. |
| Tumor necrosis rate | 5 years | The percentage of tumor necrosis calculated in the resected specimen in Arm 2. |
Countries
China
Contacts
Primary ContactJie Xu, M.D.
Backup ContactXie Lu, M.D.
Outcome results
None listed