ClinicalTrials.Veeva

Menu

Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

P

Peking University

Status

Enrolling

Conditions

Osteosarcoma of Pelvis

Treatments

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

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)

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: Ifosfamide
Procedure: definitive surgery
Drug: Cisplatin
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: Ifosfamide
Procedure: definitive surgery
Drug: Cisplatin
Drug: Doxorubicin
Drug: Methotrexate

Trial contacts and locations

1

Loading...

Central trial contact

Jie Xu, M.D.; Xie Lu, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems