protocolSection identificationModule nctId: NCT06341712, orgStudyIdInfo id: CLIN-60000-461, secondaryIdInfos id: 2023-506229-12-00, type: OTHER, domain: Ipsen, briefTitle: Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma, acronym: CabOSTar, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-13, primaryCompletionDateStruct date: 2026-10-26, completionDateStruct date: 2028-06-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ipsen, class: INDUSTRY, descriptionModule briefSummary: The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery.Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid.Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults.In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator's discretion and according to institutional guidelines.It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy.Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met.Participants may withdraw consent to participate at any time.The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit., conditionsModule conditions: Osteosarcoma, conditions: Osteosarcoma in Children, conditions: Osteosarcoma in Adolescents and Young Adults, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Cabozantinib, interventions name: Best Supportive Care (BSC), interventions name: Best Supportive Care (BSC), outcomesModule primaryOutcomes measure: Progression-free Survival (PFS) assessed by Blinded Independent Radiology Committee (BIRC), secondaryOutcomes measure: Progression-free survival (PFS) rate assessed by BIRC, secondaryOutcomes measure: Objective response rate (ORR) assessed by BIRC, secondaryOutcomes measure: Disease control rate (DCR) assessed by BIRC, secondaryOutcomes measure: PFS assessed by investigator, secondaryOutcomes measure: PFS rate assessed by investigator, secondaryOutcomes measure: ORR assessed by investigator, secondaryOutcomes measure: DCR assessed by investigator, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 1-year overall survival rate, secondaryOutcomes measure: Percentage of participants with Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)., secondaryOutcomes measure: Area Under Curve (AUC) at steady state., secondaryOutcomes measure: Average concentration (Cavg) at steady state, secondaryOutcomes measure: Minimum concentration (Cmin) at steady state, secondaryOutcomes measure: Maximal concentration (Cmax) at steady state, secondaryOutcomes measure: Acceptability and palatability in children and adolescents assessed using a horizontal visual assessment scale., secondaryOutcomes measure: Change from baseline in score for all Paediatric QoL Inventory (PedsQL) Scales including Generic Core Scales and Cancer Modules., secondaryOutcomes measure: Change from baseline in European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) for adult participants, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False