Osteosarcoma in ChildrenPhase 2NCT07560826
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
A Phase 2 study testing High-dose Methotrexate in people with Osteosarcoma in Children and Osteosarcoma in Adolescents and Young Adults, run by Wake Forest University Health Sciences at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 22 years
- Conditions the study is for
- Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
- What is being tested?
- High-dose Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Oct 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
- 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).
- 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.
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- 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)
- 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.
- Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.
- 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).
- Participants must be willing and able to comply with all study procedures for the entire length of the study.
Who cannot join
- 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.
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Juanita Cuffree, MPH, 919-966-0017, cuffree@med.unc.edu
Ian Davis, MD, PhD
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Monica Martino, 843-792-1465, cto-peds-onc@musc.edu
Jacqueline Kraveka, DO
- Recruiting
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203
Jontyce Green, BSN, 980-442-2356, Jontyce.Green@advocatehealth.org
Thomas Russell, MD
- Not yet recruiting
Novant Health Hemby Children's Hospital
Charlotte, North Carolina, 28204
Eliana Sanchez-Ocampo, 704-384-1199, Eliana.Sanchez@novanthealth.org
Jessica Bell, MD
- Not yet recruiting
Prisma Health Midlands
Columbia, South Carolina, 29203
Carrie Ross, RN, BSN, 803-434-7099, Carrie.Ross@PrismaHealth.org
Chandni Dargan, MD
- Not yet recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Morgan Low, MSW, 919-613-1895, morgan.low@duke.edu
Jessica Sun, MD
- Not yet recruiting
East Carolina University
Greenville, North Carolina, 27834
Tori Donadio, MPH, 252-744-2301, donadiov21@ecu.edu
Andrea Whitfield, DO
- Not yet recruiting
Prisma Health Upstate
Greenville, South Carolina, 29605
Tranaka Fuqua, MBA, CCRP, BSN, RN, 864-455-5158, Tranaka.Fuqua@prismahealth.org
Chandni Dargan, MD
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Nicole Johnson, BS, 336-702-4498, nicole.johnson3@advocatehealth.org
Sarah Supples, MD
About this study
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:
Read more
- 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.
Read the detailed description
This Phase II, multi-institutional study evaluates the safety of hospital discharge at higher serum methotrexate (MTX) levels in children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma receiving standard-of-care high-dose methotrexate (HD-MTX) as part of MAP chemotherapy.
Participants are discharged once they meet the pre-defined MTX clearance, kidney function, and clinical safety criteria. Methotrexate discharge thresholds are evaluated using an adaptive Bayesian threshold-finding design, starting at a serum MTX level of less than or equal to 0.15 micromolar, with possible escalation or de-escalation based on observed toxicity.
Secondary objectives include comparison of hospital length of stay and estimated inpatient costs with historical controls using traditional discharge criteria. Optional correlative studies include patient-derived osteosarcoma tumor organoids and circulating tumor cells to evaluate chemotherapy sensitivity and other future research. A separate retrospective chart review of prior patients treated with HD-MTX is included to understand safety outcomes and MTX clearance patterns.
- Being tested
- High-dose Methotrexate
- Keywords
- Osteosarcoma, CATSINDO, Organoids, Interventional
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose MethotrexateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge | Experimental | Participants with newly diagnosed high-grade osteosarcoma receive standard-of-care MAP chemotherapy, including high-dose methotrexate (HD-MTX), with hospital discharge based on serum methotrexate threshold levels (ranging from ≤0.10 µM to ≤0.20 µM) and renal function criteria to evaluate the safety of earlier discharge. Threshold levels are not randomized and are evaluated sequentially over the course of the study. Receives: Drug: High-dose Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicity (DLT)
A binary response for dose-limiting toxicity following MTX visit discharge defined as rehospitalization due to acute toxicity or serious adverse event of special interest
Measured: Within 7-days post-discharge of methotrexate visit
Secondary outcomes (2)
Length of Stay (LOS)
Length of hospital stay measured in hours from time of admission to time of discharge for each HD-MTX inpatient cycle
Measured: From time of admission to time of discharge in hours for each HD-MTX inpatient cycle, assessed across [up to] 12 cycles per participant, through completion of HD-MTX therapy (up to approximately 30 weeks per participant from first week of treatment)
Patient Cost Per Visit
Total estimated cost associated with each HD-MTX inpatient cycle, based on hospital billing charges and nights of stay
Measured: Approximately 30 weeks per participant from first week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start31 Oct 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma in ChildrenStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
- Responsible party
- Sponsor
- Investigators
- Thomas Russell, MD, Principal investigator, Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560826
- Sponsor's protocol ID
- Pro00081644
- Other IDs
- ARISE-CATSINDO
- Status last verified
- Nov 2026
- First submitted
- 16 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
- ClinicalTrials.gov ID
- NCT07560826
- Acronym / sponsor ID
- Pro00081644
- Keywords
- Osteosarcoma, CATSINDO, Organoids, Interventional
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
- Study start
- 31 Oct 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase II, multi-institutional study evaluates the safety of hospital discharge at higher serum methotrexate (MTX) levels in children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma receiving standard-of-care high-dose methotrexate (HD-MTX) as part of MAP chemotherapy.
Participants are discharged once they meet the pre-defined MTX clearance, kidney function, and clinical safety criteria. Methotrexate discharge thresholds are evaluated using an adaptive Bayesian threshold-finding design, starting at a serum MTX level of less than or equal to 0.15 micromolar, with possible escalation or de-escalation based on observed toxicity.
Secondary objectives include comparison of hospital length of stay and estimated inpatient costs with historical controls using traditional discharge criteria. Optional correlative studies include patient-derived osteosarcoma tumor organoids and circulating tumor cells to evaluate chemotherapy sensitivity and other future research. A separate retrospective chart review of prior patients treated with HD-MTX is included to understand safety outcomes and MTX clearance patterns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge | Experimental | Drug: High-dose MethotrexateParticipants with newly diagnosed high-grade osteosarcoma receive standard-of-care MAP chemotherapy, including high-dose methotrexate (HD-MTX), with hospital discharge based on serum methotrexate threshold levels (ranging from ≤0.10 µM to ≤0.20 µM) and renal function criteria to evaluate the safety of earlier discharge. Threshold levels are not randomized and are evaluated sequentially over the course of the study. |
Who may qualify
- Ages
- 7 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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).
- 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).
Key exclusion criteria (3 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose MethotrexateHigh-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. | Drug | Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge |
Primary outcome
Incidence of Dose Limiting Toxicity (DLT)
Time frame: Within 7-days post-discharge of methotrexate visit
A binary response for dose-limiting toxicity following MTX visit discharge defined as rehospitalization due to acute toxicity or serious adverse event of special interest
2 secondary outcomes
Length of Stay (LOS)
Time frame: From time of admission to time of discharge in hours for each HD-MTX inpatient cycle, assessed across [up to] 12 cycles per participant, through completion of HD-MTX therapy (up to approximately 30 weeks per participant from first week of treatment)
Patient Cost Per Visit
Time frame: Approximately 30 weeks per participant from first week of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Russell, MD principal investigator
Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-dose Methotrexate in people with Osteosarcoma in Children and Osteosarcoma in Adolescents and Young Adults, run by Wake Forest University Health Sciences at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Neagle (980-442-2303, heather.neagle@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicity (DLT) (time frame: Within 7-days post-discharge of methotrexate visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.