Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
- Conditions
- Osteosarcoma of Pelvis
- Interventions
- Procedure: definitive surgeryOther: pre surgical chemotherapy
- Registration Number
- NCT03360760
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre surgical Chemotherapy definitive surgery 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). Immediate Surgery definitive surgery Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. Pre surgical Chemotherapy 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). Pre surgical Chemotherapy Doxorubicin 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). Pre surgical Chemotherapy Cisplatin 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). Pre surgical Chemotherapy Methotrexate 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). Pre surgical Chemotherapy Ifosfamide 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). Immediate Surgery Doxorubicin Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. Immediate Surgery Cisplatin Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. Immediate Surgery Methotrexate Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. Immediate Surgery Ifosfamide Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH.
- Primary Outcome Measures
Name Time Method Overall survival (OS) 5 years Calculated from the date of treatment start until death, whichever comes first.
- Secondary Outcome Measures
Name Time Method Tumor necrosis rate 5 years The percentage of tumor necrosis calculated in the resected specimen in Arm 2.
Progression-free survival (PFS) 5 years Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China