ABCB1/P-glycoprotein Expression Influence on Non-metastatic Osteosarcoma of the Extremities
NCT ID: NCT04383288
Last Updated: 2021-08-04
Study Results
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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COMPLETED
115 participants
OBSERVATIONAL
2014-07-02
2020-10-17
Brief Summary
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All patients included in the study will receive the initial neoadjuvant treatment prescribed by the doctor of each center, according to standard practice (involving methotrexate, cisplatin, and adriamycin). This initial treatment precedes surgical treatment.
After surgical treatment, the histological response to neoadjuvant chemotherapy will be evaluated. The histological response to primary chemotherapy will be expressed as a percentage of tumor necrosis. In the case of tumor necrosis above 90% the patient is defined as a "good responder" in case of a lower percentage as a "poor responder".
As an adjuvant treatment, the following options may be given according to standard practice in each center:
1. \- If there is overexpression of ABCB1 / P-glycoprotein and poor response to induction treatment, in many sites ifosfamide at high doses and MTP-PE, is incorporated in addition to adriamycin.
2. \- If there is overexpression of ABCB1 / P-glycoprotein and a good response to induction treatment, in many centers the option of additional administration of methotrexate, CDDP and adriamycin will be chosen.
3. \- If there is no overexpression of ABCB1 / P-glycoprotein, the administration of methotrexate, adriamycin and cisplatin will be chosen in many sites.
In some sites they will consider the non-administration of MTP-PE or the non-administration of high doses of ifosfamide. And, in some hospitals, they will consider administering MTP-PE to all patients.
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Detailed Description
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\- Disease-free survival measured as a 5-year rate in patients with localized osteosarcoma treated, according to standard practice, with all the drugs currently registered for the treatment of non-metastatic osteosarcoma (methotrexate, cisplatin, adriamycin, ifosfamide, MTP-PE), according to ABCB1 / P-glycoprotein expression.
The Secondary objectives are:
* Evaluate overall survival in a homogeneous population of patients with non-metastatic osteosarcoma.
* Disease-free survival at 2 and 3 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Overexpression of ABCB1 / P-glycoprotein. Poor response
If there is overexpression of ABCB1 / P-glycoprotein and poor response to induction treatment, in many sites ifosfamide at high doses and MTP-PE (Muramyl tripeptide phosphatidylethanolamine), is incorporated in addition to adriamycin.
BEFORE SURGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM (Adriamycin) 75mg/m2 (3 cycles)
AFTER SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total length treatment 44 weeks)
All the product are used as commercial formulation
Other Names:
Methotrexate Cisplatinum doxorubicin ifosfamide mifamurtide
No interventions assigned to this group
Overexpression of ABCB1 / P-glycoprotein. Good response
If there is overexpression of ABCB1 / P-glycoprotein and a good response to induction treatment, in many centers the option of additional administration of methotrexate, CDDP (Cisplatinum) and adriamycin will be chosen.
BEFORE SURGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
AFTER SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total length treatment 44 weeks)
All the product are used as commercial formulation
Other Names:
Methotrexate Cisplatinum doxorubicin ifosfamide mifamurtide
No interventions assigned to this group
No overexpression of ABCB1 / P-glycoprotein
If there is no overexpression of ABCB1 / P-glycoprotein, the administration of methotrexate, adriamycin and cisplatin will be chosen in many sites.
BEFORE SURGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
AFTER SURGERY TREATMENT:
Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2
Total length 34 weeks
All the product are used as commercial formulation
Other Names:
methotrexate cisplatin doxorubicine
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age: from 2 to 30 years old.
3. Localized disease (metastasis skip accepted).
4. Normal liver, kidney and spinal function.
5. Ventricular ejection fraction of 50%.
6. Absence of previous surgical treatments or chemotherapy for osteosarcoma.
7. Interval between histological diagnosis and initiation of chemotherapy not exceeding 4 weeks.
8. Signing of the consent form to participate in the study.
Exclusion Criteria
2. Parosteal, periosteal, or secondary osteosarcoma.
3. Contraindications of the medications prescribed in the protocol.
4. Pregnant or lactating.
5. Mental or social conditions that do not guarantee adequate adherence to the protocol.
6. Not having an adequate understanding of study participation.
12 Years
30 Years
ALL
No
Sponsors
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Grupo Espanol de Investigacion en Sarcomas
OTHER
Responsible Party
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Principal Investigators
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Óscar Gallego, Dr.
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Luis Gros, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d'Hebron
Locations
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Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Infantil Niño Jesús
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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References
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Palmerini E, Meazza C, Tamburini A, Marquez-Vega C, Bisogno G, Fagioli F, Ferraresi V, Milano GM, Coccoli L, Rubio-San-Simon A, Gallego O, Llinares Riestra ME, Manzitti C, Mora J, Vaz-Salgado MA, Luksch R, Mata C, Pierini M, Carretta E, Cesari M, Paioli A, Marrari A, Scotlandi K, Serra M, Asaftei SD, Gambarotti M, Picci P, Ferrari S, Valverde C, Ibrahim T, Broto JM. Is There a Role for Mifamurtide in Nonmetastatic High-Grade Osteosarcoma? Results From the Italian Sarcoma Group (ISG/OS-2) and Spanish Sarcoma Group (GEIS-33) Trials. J Clin Oncol. 2025 Oct;43(28):3113-3122. doi: 10.1200/JCO-25-00210. Epub 2025 Aug 18.
Other Identifiers
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GEIS-33
Identifier Type: -
Identifier Source: org_study_id
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