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

NCT07560826 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Osteosarcoma in Children
  • Osteosarcoma in Adolescents and Young Adults

Interventions

DRUG

High-dose Methotrexate

High-dose methotrexate (HD-MTX) is administered intravenously at a dose of 12 g/m² (maximum dose 20 g) over 4 hours as part of standard-of-care MAP chemotherapy for participants with newly diagnosed high-grade osteosarcoma. HD-MTX is delivered with standard supportive care measures, including alkalinized intravenous hydration, serial serum methotrexate level monitoring, and leucovorin rescue beginning 24 hours after methotrexate initiation and continued until discharge criteria are met. Treatment is administered according to institutional standards throughout neoadjuvant/induction and adjuvant/consolidation therapy.

Sponsors & Collaborators

  • Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Thomas Russell, MD · Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07560826 on ClinicalTrials.gov