Clinical trial • Phase III • Oncology

Zoledronic acid monohydrate for High-grade osteosarcoma

Phase III trial of Zoledronic acid monohydrate for High-grade osteosarcoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
High-grade osteosarcoma
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
06-06-2024
First CTIS Authorization Date
12-08-2024

Trial design

Randomised, standard combination chemotherapy and surgery (control) versus standard combination chemotherapy and surgery plus zometa (zoledronic acid). zometa product in record: zometa 4 mg/100 ml solution for infusion; specific dose schedule in the protocol not provided in the record. Phase III trial in France.

Randomised
Yes
Comparator
Standard combination chemotherapy and surgery (control) versus standard combination chemotherapy and surgery plus Zometa (zoledronic acid). Zometa product in record: Zometa 4 mg/100 ml solution for infusion; specific dose schedule in the protocol not provided in the record.
Target Sample Size
653
Trial Duration For Participant
1095

Eligibility

Recruits 653 paediatric patients.

Pregnancy Exclusion
Pregnancy or breast-feeding
Vulnerable Population
Unemancipated minors are included with special consent handling: "Have signed the informed consent form. For unemancipated minors, authorisation will be given by the holders of parental authority. This authorisation may be given by only one of the holders of parental authority if the other holder is unable to give his or her authorisation within a timeframe compatible with the methodological requirements for carrying out the research. Minors will receive information adapted to their capacity for understanding."

Inclusion criteria

  • {"criterion_text":"- Patient with histologically proven high-grade osteosarcoma\n- 5 years ≤ Age ≤ 50 years\n- No contraindication to the treatments envisaged\n- Not previously treated with chemo or radiotherapy for this tumour or another cancer\n- Have signed the informed consent form. For unemancipated minors, authorisation will be given by the holders of parental authority. This authorisation may be given by only one of the holders of parental authority if the other holder is unable to give his or her authorisation within a timeframe compatible with the methodological requirements for carrying out the research. Minors will receive information adapted to their capacity for understanding.\n- For which long-term follow-up is possible\n- and declared to the registration centre as soon as consent has been obtained, at the latest on the 3rd day of the first course of chemotherapy.\n- Effective contraception for women of childbearing age\n- Membership of a social security scheme"}

Exclusion criteria

  • {"criterion_text":"- Low-grade osteosarcoma\n- Bilirubin > 2 x upper normal value\n- Current or recent dental problem (< 6 weeks) including any severe infection of the teeth or jaw (mandible and maxilla), dental trauma, dental or stomatological surgery (implants). Simple dental treatment is not a contraindication. A delay of 3 weeks is required between dental avulsion and the administration of Zometa®.\n- History of osteonecrosis of the jawbone or exposure of bone or delayed healing after dental surgery.\n- Any medical abnormality incompatible with the treatments planned in this study.\n- Pregnancy or breast-feeding\n- Patients who, for family, social, geographical or psychological reasons, cannot be monitored regularly.\n- Small cell osteosarcoma\n- Maxillary osteosarcoma (due to the risk of osteonecrosis of the maxilla associated with biphosphonates)\n- Osteosarcoma operated on from the outset\n- Polymetastatic osteosarcoma with metastases considered a priori inoperable even after reduction with chemotherapy\n- Extraosseous osteosarcoma\n- Chronic disease incompatible with the protocol\n- Shortening fraction less than 28% or isotopic or echographic LVEF < 50% before treatment for patients to be treated according to the API-AI protocol\n- Calculated creatinine clearance < 70 mL/min/1.73 m²."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-free survival at 3 years.","definition_or_measurement_approach":"Event-free survival measured at 3 years (time-to-event endpoint). Specific event definition not provided in the record."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival,","definition_or_measurement_approach":"Overall survival (time from randomisation to death). Specific measurement details not provided."}
  • {"endpoint_text":"- Histological response,","definition_or_measurement_approach":"Histological response (assessment method not specified in the record)."}
  • {"endpoint_text":"- Short-term (NCI-CTC v3) and long-term toxicity,","definition_or_measurement_approach":"Toxicity assessed using NCI-CTC v3 for short-term toxicity; long-term toxicity assessment method not further specified."}
  • {"endpoint_text":"- Bone metabolism,","definition_or_measurement_approach":"Bone metabolism measures (not specified in the record)."}
  • {"endpoint_text":"- Quality of life.","definition_or_measurement_approach":"Quality of life assessment (instrument not specified)."}

Recruitment

Planned Sample Size
653
Recruitment Window Months
223
Consent Approach
Participants must have signed informed consent. For unemancipated minors, parental authority holders must provide authorisation; this may be given by only one holder if the other cannot provide authorisation within a timeframe compatible with the methodological requirements. Minors receive information adapted to their capacity for understanding. Specific assent/consent document languages beyond translations present in record are not specified.

Geography

Total Number Of Sites
56
Total Number Of Participants
653

France

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
56
Number Of Sites
56
Number Of Participants
653

Sites

Site Name
Institut Bergonie
Department Name
Service de pédiatrie
Contact Person Name
Antoine ITALIANO
Site Name
Hôpital d'enfants de Margency_Croix Rouge Française
Department Name
Service de Pédiatrie
Contact Person Name
Graziella RAIMONDO
Contact Person Email
graimondo@ctpmargency.com
Site Name
CHRU Jean Minjoz
Department Name
Hémato-Onco-Pédiatrie
Contact Person Name
Veronique LAITHIER
Contact Person Email
vlaithier@chu-besancon.fr
Site Name
Hopital Des Enfants
Department Name
Service d'Hémato-oncologie
Contact Person Name
Marie-Pierre CASTEX
Contact Person Email
castex.mp@chu-toulouse.fr
Site Name
Centre Francois Baclesse
Department Name
patrick.soulie@ico.unicancer.fr
Contact Person Name
Sabine NOAL
Contact Person Email
s.noal@baclesse.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service d'Hémato-Oncologie Pédiatrique
Contact Person Name
Joy BENADIBA
Contact Person Email
benadiba.j@chu-nice.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service d'Hématologie Oncologie Pédiatrique
Contact Person Name
Claire PLUCHART
Contact Person Email
cpluchart@chu-reims.fr
Site Name
Centre Oscar Lambret
Department Name
Service de Cancérologie Générale
Contact Person Name
Nicolas PENEL
Contact Person Email
n-penel@o-lambret.fr
Site Name
CHRU De Nancy
Department Name
Dpt d'Hémato-Onco-Pédiatrie & Transplantation Médullaire
Contact Person Name
Ludovic MANSUY
Contact Person Email
lu.mansuy@chu-nancy.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Medical oncology
Contact Person Name
Olivier COLLARD
Contact Person Email
olivier.collard@icloire.fr
Site Name
Besancon University Hospital Center
Department Name
Service d'Oncologie Médicale
Contact Person Name
Loïc CHAIGNEAU
Contact Person Email
lchaigneau@chu-besancon.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Medical oncology
Contact Person Name
Justyna KANOLD
Contact Person Email
jkanold@chu-clermontferrand.fr
Site Name
Trousseau Hospital
Department Name
Service d'Hématologie Oncologie Pédiatrique
Contact Person Name
Marie-Dominique TABONE
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service d'hémato-pédiatrie
Contact Person Name
Virginie GANDEMER
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de Pédiatrie et d'oncologie Pédiatrique
Contact Person Name
Gabriel REVON-RIVIERE
Contact Person Email
gabriel.revon-riviere@ap-hm.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service d'Oncologie Médicale
Contact Person Name
Emmanuelle BOMPAS
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Service d'Oncologie Médicale
Contact Person Name
Patrick SOULIE
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Medical oncology
Contact Person Name
Jean-Emmanuel KURTZ
Contact Person Email
je.kurtz@icans.eu
Site Name
Hôpital de la Timone
Department Name
Service d'oncologie médicale-Pr Favre
Contact Person Name
Florence DUFFAUD
Contact Person Email
florence.duffaud@mail.ap-hm.fr
Site Name
Centre Leon Berard (Lyon)
Department Name
Service de Pédiatrie
Contact Person Name
Perrine MAREC-BERARD
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service d'Onco-Hématologie
Contact Person Name
Christophe PIGUET
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Département de Pédiatrie et Génétique Médicale
Contact Person Name
Liana-Stefania CARAUSU
Contact Person Email
liana.carausu@chu-brest.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Service d'Oncologie Médicale
Contact Person Name
Didier CUPISSOL
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de pédiatrie 3 - Unité de Pédiatrie Onco-Hématologie
Contact Person Name
Natacha ENTZ-WERLE
Site Name
Institut Paoli Calmettes
Department Name
Service d'oncologie Médicale
Contact Person Name
François BERTUCCI
Contact Person Email
bertuccif@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d'Hémato-Oncologie Pédiatrique
Contact Person Name
Catherine DEVOLDERE
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Service d'Oncologie médicale
Contact Person Name
Christophe PERRIN
Contact Person Email
c.perrin@rennes.unicancer.fr
Site Name
Centre Oscar Lambret (Lille)
Department Name
Unité d'Oncologie Pédiatrique
Contact Person Name
Cyril LERVAT
Contact Person Email
c-lervat@o-lambret.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Sce d'Hématologie Oncologie Pédiatrique
Contact Person Name
Claire BRIANDET
Contact Person Email
claire.briandet@chu-dijon.fr
Site Name
Centre Henri Becquerel
Department Name
Sce d'Oncologie médicale
Contact Person Name
Cécile GUILEMET
Site Name
Institut Gustave Roussy
Department Name
jean-christophe.eymard@reims.unicancer.fr
Contact Person Name
Axel Le CESNE
Contact Person Email
axel.lecesne@gustaveroussy.fr
Site Name
Institut Curie (Paris)
Department Name
Service d'Oncologie Médicale
Contact Person Name
Sophie PIPERNO- NEUMANN
Site Name
CHU Nantes - HME-Department onco-hematology pédiatric
Department Name
Service d'onco-pédiatrie
Contact Person Name
Estelle LECULĖE-THEBAUD
Contact Person Email
estelle.thebaud@chu-nantes.fr
Site Name
Pellegrin Hospital
Department Name
Service d'onco-hématologie Pédiatrique
Contact Person Name
Cécile VERITÉ-GOULARD
Contact Person Email
cecile.verite@chu-bordeaux.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Département d'Oncologie Médicale
Contact Person Name
Thibaud VALENTIN
Site Name
Centre Leon Berard (Lyon) - additional site
Department Name
Service d'Oncologie Médicale
Contact Person Name
Isabelle RAY-COQUARD
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Département de Pédiatrie
Contact Person Name
Séverine BOBILLIER CHAUMONT
Site Name
Centre Jean Perrin (patient organisation)
Department Name
Medical oncology
Contact Person Name
Jacques-Olivier BAY
Contact Person Email
jobay@chu-clermontferrand.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Unité d'Hématologie-Oncologie-Immunologie Pédiatrique
Contact Person Name
Isabelle PELLIER
Contact Person Email
IsPellier@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne (additional)
Department Name
Service d'hématologie et oncologie pédiatrique
Contact Person Name
Claire BERGER
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Sce d'Hémato-Oncologie Pédiatrique
Contact Person Name
Odile LEJARS
Contact Person Email
o.lejars@chu-tours.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Service d'Oncologie Médicale
Contact Person Name
Maria RIOS
Contact Person Email
m.rios@nancy.unicancer.fr
Site Name
Centre Antoine Lacassagne
Department Name
Service d'Onco-Hématologie
Contact Person Name
Esma SAADA-BOUZID
Site Name
Institut Godinot
Department Name
Service d'Oncologie Médicale
Contact Person Name
Jean-Christophe EYMARD
Site Name
Institut Curie (Paris) - additional site
Department Name
Service de Pédiatrie
Contact Person Name
Sarah WINTER
Contact Person Email
sarah.winter@curie.fr
Site Name
Institut Gustave Roussy (Villejuif) - additional site
Department Name
Service Oncologie Pédiatrique
Contact Person Name
Nathalie GASPAR
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d'Hématologie Oncologie Pédiatrique
Contact Person Name
Frederic MILLOT
Contact Person Email
f.millot@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Montpellier (additional)
Department Name
Service Pédiatrie 3 Hémato-Onco-Pédiatrique
Contact Person Name
Laure SAUMET
Contact Person Email
l-saumet@chu-montpellier.fr
Site Name
Centre Jean Perrin (Clermont Ferrand) - additional
Department Name
Service Oncologie
Contact Person Name
BAY Jacques-Olivier
Contact Person Email
jobay@chu-clermontferrand.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours - additional
Department Name
Service d'Oncologie Médicale & des Maladies du Sang
Contact Person Name
Claude LINASSIER
Contact Person Email
linassier@med.univ-tours.fr
Site Name
CHU de Rouen - Hôpital Charles Nicolle
Department Name
Service de Pédiatrie et Génétique Médicale
Contact Person Name
Pascale SCHNEIDER
Contact Person Email
pascale.schneider@chu-rouen.fr
Site Name
Institut Gustave Roussy (Villejuif) - additional
Department Name
Service Oncologie Pédiatrique
Contact Person Name
Nathalie GASPAR (duplicate site entry)
Site Name
Centre Hospitalier Universitaire De Poitiers - additional
Department Name
Unité d'Onco-Hématologie Pédiatrique
Contact Person Name
Frederic MILLOT (duplicate)
Contact Person Email
f.millot@chu-poitiers.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Service Oncologie Médicale
Contact Person Name
Nicolas ISAMBERT
Contact Person Email
nisambert@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne - medical oncology
Department Name
Medical oncology
Contact Person Name
Pierre FOURNEL
Contact Person Email
pierre.fournel@icloire.fr

Sponsor

Primary sponsor

Full Name
Unicancer
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Zometa 4 mg/100 ml solution for infusion
Active Substance
Zoledronic acid monohydrate
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number EU/1/01/176/007)
Maximum Dose
40 mg
Combination Treatment
Yes

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