Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

August 25, 2018 updated by: GUO WEI, Peking University People's Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre surgical Chemotherapy
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).
Drug: Doxorubicin
60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • Adriamycin
Drug: Cisplatin
100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • cisplatinum
  • platamin
Drug: Methotrexate
High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • HD-MTX
Drug: Ifosfamide
12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • ifosphamide
Procedure: definitive surgery
Including limb-sparing procedure and amputation
Other: pre surgical chemotherapy
chemotherapy that given before definitive surgery
Other Names:
  • neoadjuvant chemotherapy
Other: Immediate Surgery
Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH.
Drug: Doxorubicin
60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • Adriamycin
Drug: Cisplatin
100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • cisplatinum
  • platamin
Drug: Methotrexate
High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • HD-MTX
Drug: Ifosfamide
12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
Other Names:
  • ifosphamide
Procedure: definitive surgery
Including limb-sparing procedure and amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years
Calculated from the date of treatment start until death, whichever comes first.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 5 years
Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
5 years
Tumor necrosis rate
Time Frame: 5 years
The percentage of tumor necrosis calculated in the resected specimen in Arm 2.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Wei Guo, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 25, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-sarcoma 04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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