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Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (SARCOME13)

Primary Purpose

Osteosarcoma

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Mifamurtide
EI or M-API regimen depending on patient age
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring Bone, Neoplasm, bone tissue, Acetylmuramyl-Alanyl-Isoglutamine

Eligibility Criteria

undefined - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Registration Criteria:

  1. All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease
  2. Age >2 years and ≤50 years;
  3. Normal haematological, renal, cardiac and hepatic functions
  4. Planned neoadjuvant chemotherapy as follows:

    1. Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years
    2. Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years
  5. Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure
  6. Affiliation to a social insurance regimen

Inclusion Criteria:

  1. Patient with a histologically proven, confirmed by experts pathologists panel (before surgery at the latest), high-grade osteosarcoma
  2. Registered at diagnosis into the study
  3. Primary tumour resected after pre-operative chemotherapy
  4. Osteosarcoma classified as high risk because of at least one risk factor:

    1. presence of distant metastases or skip metastases at diagnosis
    2. and/or poor histological response to pre-operative chemotherapy (>10% residual viable cells on the analysis of the primary tumour surgical specimen)
  5. Pre-operative chemotherapy combining

    1. Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years
    2. Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years
  6. Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to randomisation:

    1. Absolute neutrophil count ≥1.0 x 10⁹/L
    2. Platelets ≥100 x 10⁹/L
    3. Haemoglobin ≥8.0 g/mL
    4. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) in the absence of liver metastases or ≤5 x ULN in the presence of liver metastases
    5. Total Bilirubin ≤2 x ULN (except Gilbert Syndrome: <3.0 mg/dL) or Total Bilirubin ≤5.0 x ULN in the presence of liver metastases
    6. Creatinine clearance ≥60 mL/min/1.73 m² according to the Schwartz or Cockcroft formula according to patient's age
  7. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation
  8. Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.
  9. Patient fit to undergo protocol treatment and follow-up
  10. Affiliation to a social insurance regimen

Exclusion Criteria:

  1. Low grade osteosarcoma, parosteal or periosteal osteosarcoma
  2. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years.
  3. Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy
  4. Progressive disease at any site under initial chemotherapy, confirmed before randomisation time, and not totally resected during surgery
  5. Any medical condition precluding treatment with protocol chemotherapy
  6. Fractional Shortening <28% or left ventricular ejection fraction (LVEF) 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or multigated acquisition (MUGA) scan
  7. Pregnancy or breast-feeding
  8. Hypersensitivity to the active substance or to any of the excipients
  9. Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors
  10. Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)
  11. Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped.
  12. Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  13. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.

Sites / Locations

  • CHU Amiens-Picardie - Service d'oncologie hématologie pédiatriqueRecruiting
  • CHU d'Angers - Service d'oncologie pédiatriqueRecruiting
  • Institut Bergonié - Service d'oncologie médicaleRecruiting
  • CHU de Caen - Service d'oncologie hématologie pédiatriqueRecruiting
  • CHU de Grenoble - Service d'oncologie hématologie pédiatriqueRecruiting
  • Centre Oscar Lambret - Unité d'onco-pédiatrieRecruiting
  • Centre Léon Bérard - IHOPERecruiting
  • Centre Léon Bérard - Service d'oncologie médicaleRecruiting
  • Hôpital de la Timone - service d'oncologie médicaleRecruiting
  • Hôpital de la Timone - Service d'oncologie pédiatriqueRecruiting
  • CHU Arnaud de Villeneuve - Onco-hématologie pédiatriqueRecruiting
  • Institut régional du Cancer de Montpellier - Service d'oncologie médicaleRecruiting
  • CHU de Nantes - Service d'oncologie hématologie pédiatriqueRecruiting
  • CHU de Nice - Service d'oncologie hématologie pédiatriqueRecruiting
  • Institut Curie - Service d'oncologie médicaleRecruiting
  • Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatriqueRecruiting
  • Hôpital CochinRecruiting
  • Institut Curie - Service d'oncologie pédiatriqueRecruiting
  • Centre Eugène Marquis - Service d'oncologie médicaleRecruiting
  • Hôpital Charles Nicolle - Hémato-Immuno-Oncologie PédiatriqueRecruiting
  • Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicaleRecruiting
  • Hôpital de Hautepierre - Onco-hématologie adulteRecruiting
  • Hôpital Hautepierre - Onco-hématologie pédiatriqueRecruiting
  • CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-OncologieRecruiting
  • Institut Claudius Regaud - service d'oncologie médicaleRecruiting
  • CHU Bretonneau - Service d'oncologie médicaleRecruiting
  • Hôpital Clocheville - Hématologie et oncologie pédiatriqueRecruiting
  • CHRU de Nancy - Onco-hématologie pédiatriqueRecruiting
  • Institut de Cancérologie de Lorraine - Service d'oncologie médicaleRecruiting
  • Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescentRecruiting
  • Institut Gustave Roussy - Service d'oncologie médicaleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Experimental arm

Arm Description

Post-operative chemotherapy alone (EI or M-API regimen depending on patient age) : M-API regimen (≤25 years) : Doxorubicin 60 mg/m², Day 1 Ifosfamide 3 g/m² Day 1 and 2 Cisplatin 100 mg/m², Day 2 EI regimen (26-50 years) : Etoposide 75 mg/m²/d, Day 1-4 Ifosfamide 3 g/m²/d, Day 1-4

Post-operative chemotherapy (EI or M-API regimen) combined with Mifamurtide 2 mg/m² twice weekly post-randomisation for 12 weeks then weekly for 24 weeks

Outcomes

Primary Outcome Measures

Compare event-free survival in the treatment arms
Event-free survival defined as the time duration from randomisation to time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause)

Secondary Outcome Measures

Compare overall survival in the treatment arms
Overall survival defined as the time duration from randomisation to death, whatever the cause of death
Compare actual and planned cumulative dose and dose intensity of mifamurtide
Calculation of actual cumulative dose and dose intensity compared to the planned treatment administration schedule
Compare the incidence of adverse events in the treatment arms
Evaluation of toxicity (graded by NCI-CTCAE v4)

Full Information

First Posted
July 11, 2018
Last Updated
December 8, 2022
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT03643133
Brief Title
Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
Acronym
SARCOME13
Official Title
Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).
Detailed Description
Multicentre, randomised, open-label, phase II trial, with 2 parallel groups. After pre-operative chemotherapy and surgery of the primary tumour and lung metastases (if applicable), patients presenting high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) will be randomised between 2 arms: Control arm: post-operative chemotherapy alone (with regimens adapted to the age of patient) Experimental arm : post-operative chemotherapy combined with mifamurtide This randomised trial is part of a study recruiting all patients ≤50 years old with a newly diagnosed high-grade osteosarcoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
Bone, Neoplasm, bone tissue, Acetylmuramyl-Alanyl-Isoglutamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Post-operative chemotherapy alone (EI or M-API regimen depending on patient age) : M-API regimen (≤25 years) : Doxorubicin 60 mg/m², Day 1 Ifosfamide 3 g/m² Day 1 and 2 Cisplatin 100 mg/m², Day 2 EI regimen (26-50 years) : Etoposide 75 mg/m²/d, Day 1-4 Ifosfamide 3 g/m²/d, Day 1-4
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Post-operative chemotherapy (EI or M-API regimen) combined with Mifamurtide 2 mg/m² twice weekly post-randomisation for 12 weeks then weekly for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Mifamurtide
Other Intervention Name(s)
MEPACT
Intervention Description
48 doses overall over 36 weeks
Intervention Type
Combination Product
Intervention Name(s)
EI or M-API regimen depending on patient age
Intervention Description
M-API regimen: One course of high-dose Methotrexate (optional) followed by 5 courses of API, every 21 days EI regimen : 5 course of EI, every 21 days
Primary Outcome Measure Information:
Title
Compare event-free survival in the treatment arms
Description
Event-free survival defined as the time duration from randomisation to time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause)
Time Frame
Expected average duration of 3 years from randomization
Secondary Outcome Measure Information:
Title
Compare overall survival in the treatment arms
Description
Overall survival defined as the time duration from randomisation to death, whatever the cause of death
Time Frame
Up to 10 years from randomization
Title
Compare actual and planned cumulative dose and dose intensity of mifamurtide
Description
Calculation of actual cumulative dose and dose intensity compared to the planned treatment administration schedule
Time Frame
Up to 36 weeks from randomization (until end of treatment)
Title
Compare the incidence of adverse events in the treatment arms
Description
Evaluation of toxicity (graded by NCI-CTCAE v4)
Time Frame
Up to 40 weeks from randomization (4 weeks after end of treatment)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Registration Criteria: All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease Age >2 years and ≤50 years; Normal haematological, renal, cardiac and hepatic functions Planned neoadjuvant chemotherapy as follows: Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure Affiliation to a social insurance regimen Inclusion Criteria: Patient with a histologically proven, confirmed by experts pathologists panel (before surgery at the latest), high-grade osteosarcoma Registered at diagnosis into the study Primary tumour resected after pre-operative chemotherapy Osteosarcoma classified as high risk because of at least one risk factor: presence of distant metastases or skip metastases at diagnosis and/or poor histological response to pre-operative chemotherapy (>10% residual viable cells on the analysis of the primary tumour surgical specimen) Pre-operative chemotherapy combining Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to randomisation: Absolute neutrophil count ≥1.0 x 10⁹/L Platelets ≥100 x 10⁹/L Haemoglobin ≥8.0 g/mL Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) in the absence of liver metastases or ≤5 x ULN in the presence of liver metastases Total Bilirubin ≤2 x ULN (except Gilbert Syndrome: <3.0 mg/dL) or Total Bilirubin ≤5.0 x ULN in the presence of liver metastases Creatinine clearance ≥60 mL/min/1.73 m² according to the Schwartz or Cockcroft formula according to patient's age Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses. Patient fit to undergo protocol treatment and follow-up Affiliation to a social insurance regimen Exclusion Criteria: Low grade osteosarcoma, parosteal or periosteal osteosarcoma Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years. Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy Progressive disease at any site under initial chemotherapy, confirmed before randomisation time, and not totally resected during surgery Any medical condition precluding treatment with protocol chemotherapy Fractional Shortening <28% or left ventricular ejection fraction (LVEF) 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or multigated acquisition (MUGA) scan Pregnancy or breast-feeding Hypersensitivity to the active substance or to any of the excipients Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors) Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped. Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline MAHIER
Phone
+33144235584
Email
c-mahier@unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie MD GASPAR, PhD
Organizational Affiliation
Gustave Roussy Cancer Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie MD PIPERNO-NEUMANN, PhD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr GOURMEL
Facility Name
CHU d'Angers - Service d'oncologie pédiatrique
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr PROUST
Facility Name
Institut Bergonié - Service d'oncologie médicale
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr ITALIANO
Facility Name
CHU de Caen - Service d'oncologie hématologie pédiatrique
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr DEPARIS
Facility Name
CHU de Grenoble - Service d'oncologie hématologie pédiatrique
City
La Tronche
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr PLANTAZ
Facility Name
Centre Oscar Lambret - Unité d'onco-pédiatrie
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr LERVAT
Facility Name
Centre Léon Bérard - IHOPE
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr MAREC-BERARD
Facility Name
Centre Léon Bérard - Service d'oncologie médicale
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr BLAY
Facility Name
Hôpital de la Timone - service d'oncologie médicale
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr DUFFAUD
Facility Name
Hôpital de la Timone - Service d'oncologie pédiatrique
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr GENTET
Facility Name
CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr HAOUY
Facility Name
Institut régional du Cancer de Montpellier - Service d'oncologie médicale
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr CUPISSOL
Facility Name
CHU de Nantes - Service d'oncologie hématologie pédiatrique
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr CLEIREC
Facility Name
CHU de Nice - Service d'oncologie hématologie pédiatrique
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr BENABIDA
Facility Name
Institut Curie - Service d'oncologie médicale
City
Paris
ZIP/Postal Code
75000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr PIPERNO-NEUMANN
Facility Name
Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr TABONE
Facility Name
Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr BOUDOU-ROUQUETTE
Facility Name
Institut Curie - Service d'oncologie pédiatrique
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr PACQUEMENT
Facility Name
Centre Eugène Marquis - Service d'oncologie médicale
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr PERRIN
Facility Name
Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr SCHNEIDER
Facility Name
Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale
City
Saint-Herblain
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr BOMPAS
Facility Name
Hôpital de Hautepierre - Onco-hématologie adulte
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr KURTZ
Facility Name
Hôpital Hautepierre - Onco-hématologie pédiatrique
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr ENTZ-WERLE
Facility Name
CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr CASTEX
Facility Name
Institut Claudius Regaud - service d'oncologie médicale
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr CHEVREAU
Facility Name
CHU Bretonneau - Service d'oncologie médicale
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr NARCISSO
Facility Name
Hôpital Clocheville - Hématologie et oncologie pédiatrique
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr SERRE
Facility Name
CHRU de Nancy - Onco-hématologie pédiatrique
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr MANSUY
Facility Name
Institut de Cancérologie de Lorraine - Service d'oncologie médicale
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr RIOS
Facility Name
Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr GASPAR
Facility Name
Institut Gustave Roussy - Service d'oncologie médicale
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr DUMONT

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared at an individual level, they will be part of the study database including all enrolled patients.
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
31110092
Citation
Brard C, Piperno-Neumann S, Delaye J, Brugieres L, Hampson LV, Le Teuff G, Le Deley MC, Gaspar N. Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. BMJ Open. 2019 May 19;9(5):e025877. doi: 10.1136/bmjopen-2018-025877.
Results Reference
derived

Learn more about this trial

Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients

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