Could kids with bone cancer go home sooner after chemo?
NCT ID NCT07560826
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study looks at whether children, teens, and young adults with newly diagnosed osteosarcoma can safely leave the hospital when their methotrexate levels are slightly higher than usual after standard chemotherapy. The goal is to shorten hospital stays without increasing side effects or readmissions. About 46 participants aged 22 or younger will be monitored, and researchers will also try to grow tumor samples in the lab for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-dose methotrexate
- What this could lead to
- If successful, this could allow earlier hospital discharge after chemotherapy, reducing hospital stays and costs for young osteosarcoma patients.
- What could go wrong
- This is a small, early-phase trial with only 46 participants, so results may not apply to all patients. There is a risk of side effects or rehospitalization with higher methotrexate levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 22 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Pre-Enrollment Criteria: 1. Suspected diagnosis of high-grade osteosarcoma based on clinical and radiographic findings. 2. Informed consent (and assent, if applicable) obtained, per institutional guidelines. 3. Participants must be ≤ 22 years of age at the time of consent. Inclusion Criteria: 1. Participants with localized or metastatic high-grade osteosarcoma. 2. Participants must be ≤ 22 years of age at the time of consent. 3. Participants must have a body surface area of greater than or equal to 0.8 m2. 4. 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). NOTE: Participants may be participating on other clinical studies such as the COG trial AOST2032 or any other clinical trial as long as their treatment includes MAP chemotherapy with the standard HD-MTX dose of 12 gm/m2 (maximum 20 gm). 5. 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. 6. Participants must meet minimum organ function requirements to receive HD-MTX: * Adequate liver function defined as: total bilirubin ≤ 1.5x upper limit of normal (ULN) for age at the time of consent and alanine aminotransferase (ALT/SGPT) ≤ 135 U/L for age at the time of consent. * Adequate renal function defined as: a serum creatinine based on age/gender OR - a 24-hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2, OR - an estimated glomerular filtration rate (GFR) of greater than or equal to 70 mL/min/1.73 m2 for age at the time of consent. * Adequate bone marrow function defined as: peripheral absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment), and hemoglobin ≥ 8.0 g/dL (transfusion independent, defined as not receiving red blood cell transfusions within a 7-day period prior to enrollment) 7. 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). NOTE: Cardiac function assessment will be performed as part of routine clinical care. No additional imaging or procedures will be mandated by the research protocol. 8. Informed consent, and assent when appropriate, must be obtained, per institutional guidelines. 9. Participants can enroll after initiation of induction MAP chemotherapy so long as they are enrolled prior to the second cycle of chemotherapy (prior to week 6 cisplatin and doxorubicin). 10. Participants must be willing and able to comply with all study procedures for the entire length of the study. Exclusion Criteria: 1. Female participants who are pregnant and/or lactating and breast feeding their infant(s). NOTE: Pregnancy testing will follow institutional standard of care practice and is not mandated by the protocol. 2. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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East Carolina University
Greenville, North Carolina, 27834, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Novant Health Hemby Children's Hospital
Charlotte, North Carolina, 28204, United States
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Prisma Health Midlands
Columbia, South Carolina, 29203, United States
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Prisma Health Upstate
Greenville, South Carolina, 29605, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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