Clinical trial • Phase III • Oncology|Immunology
METHYLPREDNISOLONE HEMISUCCINATE for Digestive cancer
Phase III trial of METHYLPREDNISOLONE HEMISUCCINATE for Digestive cancer.
Overview
- Trial Therapeutic Area
- Oncology|Immunology
- Trial Disease
- Digestive cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-06-2024
- First CTIS Authorization Date
- 15-07-2024
Trial design
Randomised, methylprednisolone (solumedrol / methylprednisolone viatris) — intravenous infusion; dosing unit mg/kg, max total dose 20 mg/kg; placebo: sodium chloride (solution for infusion) — intravenous infusion; max total amount 50 ml.-controlled Phase III trial across 25 sites in France.
- Randomised
- Yes
- Comparator
- Methylprednisolone (SOLUMEDROL / METHYLPREDNISOLONE VIATRIS) — intravenous infusion; dosing unit mg/kg, max total dose 20 mg/kg; Placebo: Sodium chloride (solution for infusion) — intravenous infusion; max total amount 50 ml.
- Target Sample Size
- 1200
- Trial Duration For Participant
- 1095
Eligibility
Recruits 1200 Vulnerable population not selected. Persons subject to legal protection (curatelle, tutelle) or subject to a court order are explicitly excluded. Written informed consent is required from participants..
- Pregnancy Exclusion
- Pregnant or breastfeeding women
- Vulnerable Population
- Vulnerable population not selected. Persons subject to legal protection (curatelle, tutelle) or subject to a court order are explicitly excluded. Written informed consent is required from participants.
Inclusion criteria
- {"criterion_text":"- Age > or = 18 years\n- Elective surgery for any digestive cancer (except purely hepatic surgery)\n- Patients operated in a curative intent\n- Patients who had given their written informed consent\n- Patients affiliated to a National health insurance scheme"}
Exclusion criteria
- {"criterion_text":"- Emergency surgery\n- Persons subject to a court order\n- Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons\n- Secondary exclusion criteria : live vaccine or live attenuated vaccine administered within 1 month preceding surgery\n- Secondary exclusion criteria : cancelled surgery without deferral\n- Pregnant or breastfeeding women\n- Patients with an ongoing oral treatment by steroids\n- Palliative surgery\n- Exclusive liver surgery\n- concomitant hyperthermic intraperitoneal chemotherapy\n- Patient with at least one contra-indication to methylprednisolone treatment : * active infection * progressive/symptomatic viral infection(particularly hepatitis, herpes, chickenpox, herpes zoster) * uncontrolled psychotic state * hypersensitivity to methylprednisolone or to one of its excipients\n- ASA grade >3\n- Persons subject to a measure of legal protection (guardianship, tutorship)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- frequency of patients with postoperative major complications occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2","definition_or_measurement_approach":"Postoperative major complications occurring within 30 days after surgery (D30); defined as all complications with Clavien-Dindo grade > 2."}
Secondary endpoints
- {"endpoint_text":"- Efficacy: - Overall survival at 3 years (time from surgery to death from any cause)","definition_or_measurement_approach":"Overall survival at 3 years: time from surgery to death from any cause."}
- {"endpoint_text":"- Efficacy: Disease-free survival at 3 years (time from surgery to first documented progressive disease or death from any cause, whichever occurs first)","definition_or_measurement_approach":"Disease-free survival at 3 years: time from surgery to first documented progressive disease or death from any cause, whichever occurs first."}
- {"endpoint_text":"- Efficacy: Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definitions","definition_or_measurement_approach":"Frequency of postoperative infections within 30 days after surgery, defined according to CDC definitions."}
- {"endpoint_text":"- Efficacy: Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery (CDC definition)","definition_or_measurement_approach":"Frequency of intra-abdominal infections within 30 days after surgery (including anastomotic fistula and intra-abdominal abscess), using CDC definitions."}
- {"endpoint_text":"- Efficacy: Number of hospitalization days. In case of death, the patient will be considered as hospitalized until D30","definition_or_measurement_approach":"Number of hospitalization days; if patient dies, considered hospitalized until day 30."}
- {"endpoint_text":"- Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by blood samples within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up","definition_or_measurement_approach":"Frequency and type of adverse events; hyperglycemia and electrolyte disorders assessed by blood samples within first 24 postoperative hours; wound healing assessed by clinical inspection at D30."}
Recruitment
- Planned Sample Size
- 1200
- Recruitment Window Months
- 88
- Consent Approach
- Written informed consent required from participants; subject information and informed consent form available (document 'L1_SIS and ICF' listed). No assent procedures or additional languages described in the record.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 1200
France
- Earliest CTIS Part Ii Submission Date
- 02-07-2024
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 563
- Number Of Sites
- 25
- Number Of Participants
- 1200
Sites
- Site Name
- Centre Hospitalier Simone Veil De Beauvais
- Department Name
- Chirurgie Générale et Digestive
- Principal Investigator Name
- François MAUVAIS
- Principal Investigator Email
- f.mauvais@ch-beauvais.fr
- Contact Person Name
- François MAUVAIS
- Contact Person Email
- f.mauvais@ch-beauvais.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie Digestive, Hépato-biliaire et endocrinienne
- Principal Investigator Name
- Ugo MARCHESE
- Principal Investigator Email
- ugo.marchese@aphp.fr
- Contact Person Name
- Ugo MARCHESE
- Contact Person Email
- ugo.marchese@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Chirurgie Digestive et Endocrinienne
- Principal Investigator Name
- Sophie DEGUELTE
- Principal Investigator Email
- sdeguelte@chu-reims.fr
- Contact Person Name
- Sophie DEGUELTE
- Contact Person Email
- sdeguelte@chu-reims.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie pancréatique, hépato-biliaire, oncologique et endocrinienne
- Principal Investigator Name
- Sébastien GAUJOUX
- Principal Investigator Email
- sebastien.gaujoux@aphp.fr
- Contact Person Name
- Sébastien GAUJOUX
- Contact Person Email
- sebastien.gaujoux@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Chirurgie Digestive et transplantation hépatique
- Principal Investigator Name
- Astrid HERRERO
- Principal Investigator Email
- a-herrero@chu-montpellier.fr
- Contact Person Name
- Astrid HERRERO
- Contact Person Email
- a-herrero@chu-montpellier.fr
- Site Name
- Centre Hospitalier D Auxerre
- Department Name
- Chirurgie Générale et Digestive
- Principal Investigator Name
- Baptiste BORRACCINO
- Principal Investigator Email
- bborraccino@ch-auxerre.fr
- Contact Person Name
- Baptiste BORRACCINO
- Contact Person Email
- bborraccino@ch-auxerre.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Guillaume PIESSEN
- Principal Investigator Email
- guillaume.piessen@chru-lille.fr
- Contact Person Name
- Guillaume PIESSEN
- Contact Person Email
- guillaume.piessen@chru-lille.fr
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- Chirurgie viscérale
- Principal Investigator Name
- Aurélien VENARA
- Principal Investigator Email
- auvenara@chu-angers.fr
- Contact Person Name
- Aurélien VENARA
- Contact Person Email
- auvenara@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Lilian SCHWAZ
- Principal Investigator Email
- lilian.schwarz@chu-rouen.fr
- Contact Person Name
- Lilian SCHWAZ
- Contact Person Email
- lilian.schwarz@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Fabrice MUSCARI
- Principal Investigator Email
- muscari.f@chu-toulouse.fr
- Contact Person Name
- Fabrice MUSCARI
- Contact Person Email
- muscari.f@chu-toulouse.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie digestive, bariatrique et endocrinienne
- Principal Investigator Name
- Christophe TRESALLET
- Principal Investigator Email
- christophe.tresallet@aphp.fr
- Contact Person Name
- Christophe TRESALLET
- Contact Person Email
- christophe.tresallet@aphp.fr
- Site Name
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Alain François VALVERDE
- Principal Investigator Email
- avalverde@hopital-dcss.org
- Contact Person Name
- Alain François VALVERDE
- Contact Person Email
- avalverde@hopital-dcss.org
- Site Name
- HOPITAL ROBERT SCHUMAN DE VANTOUX
- Department Name
- Chirurgie viscérale, endocrinienne et métabolique
- Principal Investigator Name
- Cyrille BUISSET
- Principal Investigator Email
- cyrille.buisset@uneos.fr
- Contact Person Name
- Cyrille BUISSET
- Contact Person Email
- cyrille.buisset@uneos.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Jean-Marc REGIMBEAU
- Principal Investigator Email
- regimbeau.jean-marc@chu-amiens.fr
- Contact Person Name
- Jean-Marc REGIMBEAU
- Contact Person Email
- regimbeau.jean-marc@chu-amiens.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Chirurgie Digestive et Hépato-biliaire
- Principal Investigator Name
- David ORRY
- Principal Investigator Email
- dorry@cgfl.fr
- Contact Person Name
- David ORRY
- Contact Person Email
- dorry@cgfl.fr
- Site Name
- Hopital NOVO
- Department Name
- Chirurgie viscérale et digestive
- Principal Investigator Name
- Nelson TRELLES
- Principal Investigator Email
- nelson.trelles@ght-novo.fr
- Contact Person Name
- Nelson TRELLES
- Contact Person Email
- nelson.trelles@ght-novo.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Chirurgie Générale et Digestive
- Principal Investigator Name
- Laura BEYER-BERJOT
- Principal Investigator Email
- laura.beyer@ap-hm.fr
- Contact Person Name
- Laura BEYER-BERJOT
- Contact Person Email
- laura.beyer@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Chirurgie digestive, oncologique et mini invasive
- Principal Investigator Name
- Régis SOUCHE
- Principal Investigator Email
- fr-souche@chu-montpellier.fr
- Contact Person Name
- Régis SOUCHE
- Contact Person Email
- fr-souche@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Chirurgie Digestive transplantation
- Principal Investigator Name
- Philippe ZERBIB
- Principal Investigator Email
- p-zerbib@chru-lille.fr
- Contact Person Name
- Philippe ZERBIB
- Contact Person Email
- p-zerbib@chru-lille.fr
- Site Name
- CHRU De Nancy
- Department Name
- Chirurgie cancérologique digestive, hepato bilio pancréatique et colorectale
- Principal Investigator Name
- Ahmet AYAV
- Principal Investigator Email
- a.ayav@chru-nancy.fr
- Contact Person Name
- Ahmet AYAV
- Contact Person Email
- a.ayav@chru-nancy.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- Chirurgie viscérale
- Principal Investigator Name
- Flore THIBAUT
- Principal Investigator Email
- fthibaut@ch-tourcoing.fr
- Contact Person Name
- Flore THIBAUT
- Contact Person Email
- fthibaut@ch-tourcoing.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Guillaume PASSOT
- Principal Investigator Email
- guillaume.passot@chu-lyon.fr
- Contact Person Name
- Guillaume PASSOT
- Contact Person Email
- guillaume.passot@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Chirurgie Digestive et Cancérologique
- Principal Investigator Name
- Pablo ORTEGA DEBALLON
- Principal Investigator Email
- pablo.ortega-deballon@chu-dijon.fr
- Contact Person Name
- Pablo ORTEGA DEBALLON
- Contact Person Email
- pablo.ortega-deballon@chu-dijon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie Digestive et Oncologique
- Principal Investigator Name
- Stéphane BENOIST
- Principal Investigator Email
- stephane.benoist@aphp.fr
- Contact Person Name
- Stéphane BENOIST
- Contact Person Email
- stephane.benoist@aphp.fr
- Site Name
- CHU Besancon
- Department Name
- Chirurgie Générale, Digestive et Cancérologique
- Principal Investigator Name
- Alexandre DOUSSOT
- Principal Investigator Email
- adoussot@chu-besancon.fr
- Contact Person Name
- Alexandre DOUSSOT
- Contact Person Email
- adoussot@chu-besancon.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Dijon
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- SOLUMEDROL 500 mg, poudre pour solution injectable
- Active Substance
- METHYLPREDNISOLONE HEMISUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation: 34009 386 777 4 4
- Frequency
- single preoperative dose
- Maximum Dose
- 20 mg/kg
- Investigational Product Name
- METHYLPREDNISOLONE VIATRIS 500 mg, poudre pour solution injectable
- Active Substance
- METHYLPREDNISOLONE HYDROGEN SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation: NL 21065
- Frequency
- single preoperative dose
- Maximum Dose
- 20 mg/kg
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- -
- Maximum Dose
- 50 ml
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