Clinical trial NCT03360760: Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
Official title: Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteosarcoma of Pelvis
Keywords: osteosarcoma
pelvis
sacrum
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 5 years
measure: Tumor necrosis rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Wei Guo
role: PRINCIPAL_INVESTIGATOR
References: