PERFLUTREN for Glioblastoma (IDH wild-type)

Inclusion criteria

• {"criterion_text":"- Brain MRI with suspicion of newly diagnosed IDH wild type GBM"}
• {"criterion_text":"- Supratentorial tumor"}
• {"criterion_text":"- T1W Tumor enhancement of ≤ 7cm"}
• {"criterion_text":"- Eligible for partial or complete surgical resection and for concurrent TemoRadiation followed by adjuvant TMZ (according to Stupp protocol) with or without Tumor Treating Fields* - (*Tumor Treating Fields is applicable only in participating centers in France)"}
• {"criterion_text":"- Patient ≥ 18 years, able and willing to give signed and informed consent. Inclusion for patients aged >70 years should be validated in neuro-oncology tumor board (RCP)"}
• {"criterion_text":"- KPS ≥70"}

Exclusion criteria

• {"criterion_text":"- Contra indication for sonication"}
• {"criterion_text":"- i.\tPatients with known intracranial aneurism, with and/or unremovable coils, clips, shunts, intravascular stents, wafer, non resorbable dura substitute, or reservoirs"}
• {"criterion_text":"- j.\tPatients with an uncontrolled intercurrent illness or any pre-existing comorbidities that in the Investigator’s opinion may prevent the implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud or may be cofounding for evaluation of the clinical trial"}
• {"criterion_text":"- k.\tPatients with the following are not eligible: •\tKnown arterial hypertension grade 3 or higher without adequate control on medications •\tKnown or suspected unstable active or chronic infections requiring systemic treatment •\tKnown significant cardiac disease: right-to-left shunts, Unstable angina pectoris, Symptomatic congestive heart failure, Unstable cardiac arrhythmia •\tKnown significant pulmonary disease: severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, adult respiratory distress syndrome, or Pneumonitis •\tKnown Severe renal failure •\tKnown serious myelosuppression •\tKnown Psychiatric illness/social situations that would limit compliance with study requirements •\tAny other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints •\tKnown immunodeficiency disease or treatments (HIV) •\tKnown viral or bacterial chronic/acute disease (potential blood borne infections that could result in meningitis or brain abscess) •\tCoeliac disease or wheat allergy •\tKnown liver dysfunction"}
• {"criterion_text":"- l.\tPatients under judicial protection"}
• {"criterion_text":"- m.\tPatients with any following prohibited treatments: •\tAny investigational medicinal product within 30 days prior to inclusion and during the study •\tAntibiotics with known neurotoxicity (eg, aminoglycosides, cephalosporin, quinolones), unless substitution is not possible, •\tNon-absorbable material (dura matter substitute, hemostatic agent…) •\tAny other drug according investigator to cause cerebral toxicity due to BBB opening •\tContra-indications to temozolomide"}
• {"criterion_text":"- n.\tImplantation of the SC-9 not possible according to neurosurgeon (Any patient morphological characteristics (e.g. skin thickness >9mm), which, from neurosurgeons’ opinion, prevent implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud, would be excluded)"}
• {"criterion_text":"- Contra indication Optune: If TTF treatment is initiated (only available in France), the investigator must first ensure that the patient has no contraindications to the Optune device (See page 41)"}
• {"criterion_text":"- a.\tPatients with multifocal tumor (unless all localized in a 70 mm diameter area accessible to ultrasound field) or located in posterior fossa tumor"}
• {"criterion_text":"- b.\tPatient with diffuse FLAIR abnormalities attributable to Gliomatosis"}
• {"criterion_text":"- c.\tPatients with evidence of uncontrolled intracranial pressure"}
• {"criterion_text":"- d.\tPatients with uncontrolled epilepsy"}
• {"criterion_text":"- e.\tPatients with medical need to continue antiplatelet or antithrombotic treatment"}
• {"criterion_text":"- f.\tPregnant or breastfeeding women (blood pregnancy test)"}
• {"criterion_text":"- g.\tPatients with contra-indications to MRI or known sensitivity/allergy to gadolinium, or other intravascular contrast agents"}
• {"criterion_text":"- h.\tKnown history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Luminity®/Definity®"}

Primary endpoints

• {"endpoint_text":"- PFS is defined as the time between randomization and disease progression which is the first documented tumor progression (per local Investigator assessment according to the RANO criteria) or death due to any cause.","definition_or_measurement_approach":"Time between randomization and first documented tumor progression per local investigator assessment according to RANO criteria, or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- crPFS: central review Progression Free Survival according to RANO criteria assessed by central independent review","definition_or_measurement_approach":"Central independent review assessment of Progression Free Survival according to RANO criteria."}
• {"endpoint_text":"- iPFS: immune Progression Free Survival according to iRANO criteria assessed by local investigator","definition_or_measurement_approach":"Immune PFS assessed by local investigator using iRANO criteria."}
• {"endpoint_text":"- OS: Overall Survival","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause)."}
• {"endpoint_text":"- KPS: Karnofsky Performance Status assessed at all visits until progression.","definition_or_measurement_approach":"Karnofsky Performance Status measured at all visits until progression."}
• {"endpoint_text":"- MMSE: Mini Mental Status Examination mean score assessed at randomization, pre-TemoRadiation visit, C1 (baseline after surgery/radiotherapy), C3, C6, M11 and M18 until progression.","definition_or_measurement_approach":"MMSE mean score assessed at specified visits (randomization, pre-TemoRadiation, C1, C3, C6, M11, M18) until progression."}
• {"endpoint_text":"- QLQ-C30: the C30 Quality of Life Questionnaire (QLQ) will be assessed at using the European Organization for Research and Treatment of Cancer, at randomization, pre-TemoRadiation visit, C1 (baseline after surgery/radiotherapy), C3, C6, M11 and M18 until progression.","definition_or_measurement_approach":"EORTC QLQ-C30 assessed at scheduled visits (randomization, pre-TemoRadiation, C1, C3, C6, M11, M18) until progression."}
• {"endpoint_text":"- QLQ-BN20PROM: the BN20 Quality of Life Questionnaire (QLQ) will be assessed at using the European Organization for Research and Treatment of Cancer, at randomization, pre-TemoRadiation visit, C1 (baseline after surgery/radiotherapy), C3, C6, M11 and M18 until progression.","definition_or_measurement_approach":"EORTC QLQ-BN20 assessed at scheduled visits (randomization, pre-TemoRadiation, C1, C3, C6, M11, M18) until progression."}
• {"endpoint_text":"- PainPROM: pain score from surgical area at randomization, pre-TemoRadiation visit, C1 (baseline after surgery/radiotherapy), C3, C6, M11 and M18 until progression. This will be assessed using visual analogic scale.","definition_or_measurement_approach":"Pain score from surgical area measured by visual analog scale at scheduled visits."}
• {"endpoint_text":"- EstheticalPROM: score in self-confidence concerning esthetical dimension of surgical scar at randomization, pre-TemoRadiation visit, C1 (baseline after surgery/radiotherapy), C3, C6, M11 and M18 until progression using esthetical comfort question equivalent to q39 of QLQ-BR23 questionnaire.","definition_or_measurement_approach":"Patient-reported esthetic comfort score (equivalent to QLQ-BR23 q39) at scheduled visits."}
• {"endpoint_text":"- Safety confirmation is assessed by the frequency and severity of AE (incidence of AE summarized by system organ class and/or preferred term and severity) based on the Common Terminology Criteria for Adverse Events, version 5.0.","definition_or_measurement_approach":"Safety assessed by frequency and severity of adverse events summarized by SOC/PT and graded per CTCAE v5.0."}

Belgium

Earliest CTIS Part Ii Submission Date

12-11-2024

Latest Decision Or Authorization Date

05-12-2024

Processing Time Days

23

Number Of Sites

2

Number Of Participants

9

France

Earliest CTIS Part Ii Submission Date

12-11-2024

Latest Decision Or Authorization Date

04-12-2024

Processing Time Days

22

Number Of Sites

12

Number Of Participants

54

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France