Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

Osteosarcoma of Pelvis Clinical Trial

Official title:

Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360760
• Other study ID #: PKUPH-sarcoma 04
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 2025

Study information

• Verified date: August 2018
• Source: Peking University People's Hospital
• Contact: Jie Xu, M.D.
• Phone: 86 15901040835
• Email: xujie_pkuph[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteosarcoma
• Osteosarcoma of Pelvis

Intervention

Drug:
• Doxorubicin
60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
• Cisplatin
100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
• Methotrexate
High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
• Ifosfamide
12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Procedure:
• definitive surgery
Including limb-sparing procedure and amputation

Other:
• pre surgical chemotherapy
chemotherapy that given before definitive surgery

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Calculated from the date of treatment start until death, whichever comes first.	5 years
Secondary	Progression-free survival (PFS)	Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.	5 years
Secondary	Tumor necrosis rate	The percentage of tumor necrosis calculated in the resected specimen in Arm 2.	5 years