Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

Peking University

Status: Enrolling

Conditions: Osteosarcoma of Pelvis

Treatments: Other: pre surgical chemotherapy; Drug: Cisplatin; Drug: Ifosfamide; Drug: Methotrexate; Procedure: definitive surgery; Drug: Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT03360760

PKUPH-sarcoma 04

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pre surgical Chemotherapy

Experimental group

Description:

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).

Treatment:

Drug: Cisplatin

Procedure: definitive surgery

Drug: Ifosfamide

Drug: Doxorubicin

Other: pre surgical chemotherapy

Drug: Methotrexate

Immediate Surgery

Other group

Description:

Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH.

Treatment:

Drug: Cisplatin

Procedure: definitive surgery

Drug: Ifosfamide

Drug: Doxorubicin

Drug: Methotrexate