Clinical trial · Interventional
Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy
Outpatient Chemotherapy in Pediatric Osteosarcoma: Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual.
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if giving certain combinations of chemotherapy drugs before and after surgery, mostly in the outpatient clinic instead of in the hospital, can result in fewer hospital stays during treatment for osteosarcoma. The drugs and schedules will vary depending on the status of the cancer and its level of risk for spreading, but they will include combinations of doxorubicin (non-liposomal), cisplatin, methotrexate, and ifosfamide, as described below.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Dexrazoxane | Drug | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Questionnaire | Behavioral |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Outpatient Chemotherapy
- description
- Pre-Surgery, Regimen 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m\^2/day for 2 days, Methotrexate 12 gm/m\^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen 1: Methotrexate 12 gm/m\^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m\^2 twice daily, Leucovorin Rescue.
- interventionNames
- Drug: Doxorubicin
- Drug: Cisplatin
- Drug: Methotrexate
- Drug: Leucovorin
- Behavioral: Questionnaire
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Additional Risk-Adapted Outpatient Chemotherapy
- description
- Pre-Surgery, Regimen 2: Dexrazoxane 900 mg/m\^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m\^2 (intra-arterial); Surgery; Post-Surgery, Regimen 2: Methotrexate 12 gm/m\^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m\^2/day and Mesna 2.8 gm/m\^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible. 2. Age 5-40 years old on date of diagnostic biopsy. 3. Adequate organ function: creatinine 1.6 or lower, bilirubin \<2, Hemoglobin 8 gm/dL or greater, Absolute neutrophil count (ANC) 1000 or more, platelets 100,000 or more. Cardiac ejection fraction (EF) 50% or better, hearing threshold 40 dB at 4000 Hz or better. 4. Signed informed consent. 5. Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy. Exclusion Criteria: 1. Diagnosis other than osteosarcoma. 2. Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy
References
Publications (0)
Data not yet available