Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2025-02-28

Brief Summary

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

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Detailed Description

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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

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Osteosarcoma of Pelvis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

60mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Cisplatin

Intervention Type DRUG

100mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Methotrexate

Intervention Type DRUG

High dose of methotrexate (8-12g/m\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Ifosfamide

Intervention Type DRUG

12g/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

definitive surgery

Intervention Type PROCEDURE

Including limb-sparing procedure and amputation

pre surgical chemotherapy

Intervention Type OTHER

chemotherapy that given before definitive surgery

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.

Group Type OTHER

Doxorubicin

Intervention Type DRUG

60mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Cisplatin

Intervention Type DRUG

100mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Methotrexate

Intervention Type DRUG

High dose of methotrexate (8-12g/m\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Ifosfamide

Intervention Type DRUG

12g/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

definitive surgery

Intervention Type PROCEDURE

Including limb-sparing procedure and amputation

Interventions

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Doxorubicin

60mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Intervention Type DRUG

Cisplatin

100mg/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Intervention Type DRUG

Methotrexate

High dose of methotrexate (8-12g/m\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Intervention Type DRUG

Ifosfamide

12g/m\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH

Intervention Type DRUG

definitive surgery

Including limb-sparing procedure and amputation

Intervention Type PROCEDURE

pre surgical chemotherapy

chemotherapy that given before definitive surgery

Intervention Type OTHER

Other Intervention Names

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Adriamycin cisplatinum platamin HD-MTX ifosphamide neoadjuvant chemotherapy

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No