The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma (NCT07560826) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
United States46 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
7 Years – 22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with localized or metastatic high-grade osteosarcoma.
. Participants must be ≤ 22 years of age at the time of consent.
. Participants must have a body surface area of greater than or equal to 0.8 m2.
. Participants receiving or planning to receive induction/neoadjuvant MAP chemotherapy with HD-MTX given at the standard dose of 12 gm/m2 (maximum 20 gm).
. Participants may receive other chemotherapy agents in their treatment provided that drug(s) are not known to interfere with HD-MTX clearance when given concurrently. Medications known to interfere with HD-MTX clearance are listed in Appendix A.
. Participants must meet minimum organ function requirements to receive HD-MTX:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose Limiting Toxicity (DLT)
Timeframe: Within 7-days post-discharge of methotrexate visit
. Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) ≥ 50%, assessed per institutional standard of care using non-invasive imaging modalities such as a Multi-Gated Acquisition (MUGA) scan or echocardiogram (echo).
. Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.
Exclusion criteria
. Female participants who are pregnant and/or lactating and breast feeding their infant(s).
. Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy, at the discretion of the investigator.