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The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 1 of 9 sites
  2. Recruitment opened
    • Start date moved earlier from Oct 2026 to Sep 2026
    • Study sites: 8 to 9
  3. Start date: Aug 2026 to Oct 2026
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 1 of 8 sites
  4. Start date: Jun 2026 to Aug 2026v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment. The main questions this study aims to answer are: * Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days? * Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers? Researchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels. Participants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.
Trial Details
NCT Number NCT07560826
Lead Sponsor Wake Forest University Health Sciences
Collaborators: Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
Conditions
(from sponsor)		 Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
Related terms Osteosarcoma
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov