protocolSection identificationModule nctId: NCT06356883, orgStudyIdInfo id: 2024-4938, briefTitle: Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, descriptionModule briefSummary: The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC).Putting together these data will allow to correlate clinical and radiological response to QOL and NC., conditionsModule conditions: Glioblastoma Multiforme, conditions: Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: IA Carboplatin + IA Caelyx, interventions name: IA Carboplatin + IA Etoposide Phosphate, outcomesModule primaryOutcomes measure: Tumor Response on MRI using the RANO Criteria, primaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Median overall survival, secondaryOutcomes measure: Treatment-related toxicity, secondaryOutcomes measure: Per treatment quality of life assessment, secondaryOutcomes measure: Incidence of treatment related Neurocognitive decline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHUS, status: RECRUITING, city: Sherbrooke, state: Quebec, zip: J1H 5N4, country: Canada, contacts name: David Fortin, MD, role: CONTACT, phone: 819-346-1110, phoneExt: 13895, email: david.fortin@usherbrooke.ca, contacts name: Marie-Andrée Roy, Nurse, role: CONTACT, phone: 819-346-1110, phoneExt: 13895, email: marie-andree.roy.s-inf.ciussse-chus@ssss.gouv.qc.ca, geoPoint lat: 45.40008, lon: -71.89908, hasResults: False