Clinical trial · Interventional
Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma
A Study Multicenter Randomized to Assess the Efficacy and Toxicity of Adding Metronomic Therapy to the Standard Treatment of Patients With High Grade Malignant Osteosarcoma With Metastatic Lung Disease at Diagnosis and Primary Resectable Tumor: A Study by the Latin American Group for Treatment of Osteosarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with high grade, operable, metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Maintenance therapy
- description
- 104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
- interventionNames
- Drug: Cyclophosphamide
- Drug: Methotrexate
- type
- NO_INTERVENTION
- label
- Control
- description
- 31 weeks of MAP
Primary outcomes (1)
- measure
- Efficacy and toxicity of adding metronomic therapy in disease event-free survival.
- timeFrame
- Five years
- description
- To assess the impact of adding metronome therapy to the standard treatment of patients with resectable end-stage osteosarcoma and metastatic lung disease in event-free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * A newly diagnosed patient, previously untreated, with a high degree of malignancy, confirmed by biopsy. Participant with OST as a neoplasm are also eligible * Participant with staging imaging studies performed less than four weeks. Otherwise, it should be re-staged * If pre-chemotherapy amputation is necessary, the participant will enter the study being excluded from the evaluation of tumor necrosis grade according to Huvos, but eligible for survival analysis * Participant aged ≥ 16 years should have a Karnofsky performance score\> 50 or WHO / ECOG ≥ 2 and patients \<16 years should have a Lansky performance score\> 50. Participant with a performance score impaired by the presence of a pathological fracture are eligible * Patients with normal organic function * Sexually active participant should agree to use contraceptive methods throughout the treatment * Female participant should have a negative pregnancy test Exclusion Criteria: * If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study.
References
Publications (0)
Data not yet available