Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
Study Details
Study Description
Brief Summary
To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pre surgical Chemotherapy Immediate pre surgical chemotherapy treated with four drugs including doxorubicin, cisplatin, high-dose methotrexate (MTX) and ifosfamide in eleven weeks, and then definitive surgery followed by adjuvant chemotherapy according to chemotherapy regimen in Peking University People's Hospital(PKUPH). |
Drug: Doxorubicin
60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Drug: Cisplatin
100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Drug: Methotrexate
High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Drug: Ifosfamide
12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Procedure: definitive surgery
Including limb-sparing procedure and amputation
Other: pre surgical chemotherapy
chemotherapy that given before definitive surgery
Other Names:
|
| Other: Immediate Surgery Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. |
Drug: Doxorubicin
60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Drug: Cisplatin
100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Drug: Methotrexate
High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Drug: Ifosfamide
12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
Procedure: definitive surgery
Including limb-sparing procedure and amputation
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [5 years]
Calculated from the date of treatment start until death, whichever comes first.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100034 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- Principal Investigator: Wei Guo, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PKUPH-sarcoma 04