Back to resultsComparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children
Primary Purpose
Osteosarcoma, Localised High Grade Osteosarcoma of the Limbs
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Etoposide, Ifosfamide, Methotrexate
Doxorubicin, Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring Osteosarcoma
Eligibility Criteria
Inclusion Criteria: non metastatic limb osteosarcoma, age less than 20 years, biopsy proven high-grade osteosarcoma, no previous treatment, no contraindication to chemotherapy no previous malignancy, Written informed consent. Exclusion Criteria: juxta-cortical sarcoma and microcellular anaplastic sarcoma, previous anticancer treatment contraindication to chemotherapy previous malignancy,
Sites / Locations
- Institut Gustave-Roussy
Outcomes
Primary Outcome Measures
Good histological response (5% or less viable cells) after preoperative chemotherapy
Secondary Outcome Measures
Event-free survival,
Overall survival,
Toxicity.
Full Information
NCT ID
NCT00180908
First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00180908
Brief Title
Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children
Official Title
SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Children and Adolescents Osteosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma, Localised High Grade Osteosarcoma of the Limbs
Keywords
Osteosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Etoposide, Ifosfamide, Methotrexate
Intervention Type
Drug
Intervention Name(s)
Doxorubicin, Methotrexate
Primary Outcome Measure Information:
Title
Good histological response (5% or less viable cells) after preoperative chemotherapy
Secondary Outcome Measure Information:
Title
Event-free survival,
Title
Overall survival,
Title
Toxicity.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non metastatic limb osteosarcoma,
age less than 20 years,
biopsy proven high-grade osteosarcoma,
no previous treatment,
no contraindication to chemotherapy
no previous malignancy,
Written informed consent.
Exclusion Criteria:
juxta-cortical sarcoma and microcellular anaplastic sarcoma,
previous anticancer treatment
contraindication to chemotherapy
previous malignancy,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Kalifa, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31401903
Citation
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
Results Reference
derived
PubMed Identifier
17267204
Citation
Le Deley MC, Guinebretiere JM, Gentet JC, Pacquement H, Pichon F, Marec-Berard P, Entz-Werle N, Schmitt C, Brugieres L, Vanel D, Dupouy N, Tabone MD, Kalifa C; Societe Francaise d'Oncologie Pediatrique (SFOP). SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer. 2007 Mar;43(4):752-61. doi: 10.1016/j.ejca.2006.10.023. Epub 2007 Jan 30.
Results Reference
derived
Learn more about this trial
Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children
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