Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

  • STATUS
    Recruiting
  • End date
    Feb 22, 2025
  • participants needed
    100
  • sponsor
    Peking University People's Hospital
Updated on 13 February 2022

Summary

To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.

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.

Details
Condition Osteosarcoma of Pelvis
Treatment methotrexate, cisplatin, ifosfamide, doxorubicin, Definitive Surgery, pre surgical chemotherapy
Clinical Study IdentifierNCT03360760
SponsorPeking University People's Hospital
Last Modified on13 February 2022

Eligibility

Yes No Not Sure

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
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