Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

NCT03360760 | Unknown

• 1 other identifier: PKUPH-sarcoma 04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteosarcoma of Pelvis

Keywords

osteosarcoma; pelvis; sacrum

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Calculated from the date of treatment start until death, whichever comes first.

  5 years

Secondary Outcomes (2)

• Progression-free survival (PFS)

  5 years

• Tumor necrosis rate

  5 years

Study Arms (2)

Pre surgical Chemotherapy

EXPERIMENTAL

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

Immediate Surgery

OTHER

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

Interventions

Doxorubicin DRUG

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

Also known as: Adriamycin

Immediate Surgery; Pre surgical Chemotherapy

Cisplatin DRUG

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

Also known as: cisplatinum, platamin

Immediate Surgery; Pre surgical Chemotherapy

Methotrexate DRUG

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

Also known as: HD-MTX

Immediate Surgery; Pre surgical Chemotherapy

Ifosfamide DRUG

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

Also known as: ifosphamide

Immediate Surgery; Pre surgical Chemotherapy

definitive surgery PROCEDURE

Including limb-sparing procedure and amputation

Immediate Surgery; Pre surgical Chemotherapy

pre surgical chemotherapy OTHER

chemotherapy that given before definitive surgery

Also known as: neoadjuvant chemotherapy

Pre surgical Chemotherapy

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Interventions

Doxorubicin; Cisplatin; Methotrexate; Ifosfamide; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics

Study Officials

• Wei Guo

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Xu, M.D.

CONTACT

86 15901040835; xujie_pkuph@sina.com

Xie Lu, M.D.

CONTACT

86 13401044719; sweetdoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Musculoskeletal Tumor Center

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 4, 2017
• Study Start: August 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2025
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

CN (1)