NCT03360760

Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma of Pelvis

Interventions

Type	Name	Description
DRUG	Doxorubicin	60mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
DRUG	Cisplatin	100mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
DRUG	Methotrexate	High dose of methotrexate (8-12g/m\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
DRUG	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

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-02-01
• Completion: 2025-02-01
• First posted: 2017-12-04
• Last updated: 2018-08-28

Locations

1 site across 1 country: China