Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma
NCT ID: NCT03063983
Last Updated: 2017-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
158 participants
INTERVENTIONAL
2017-01-02
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
Cyclophosphamide
Continuous oral cyclophosphamide
Methotrexate
Continuous oral methotrexate
Control
31 weeks of MAP
No interventions assigned to this group
Interventions
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Cyclophosphamide
Continuous oral cyclophosphamide
Methotrexate
Continuous oral methotrexate
Eligibility Criteria
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Inclusion Criteria
* 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
1 Day
30 Years
ALL
No
Sponsors
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Grupo de Apoio ao Adolescente e a Crianca com Cancer
OTHER
Responsible Party
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Antônio Sérgio Petrilli
Principal Investigator
Principal Investigators
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Cláudia F Fontes
Role: STUDY_CHAIR
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Locations
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Grupo de Apoio ao Adolescente e a Criança com Câncer
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GLATO2017
Identifier Type: -
Identifier Source: org_study_id
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