Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma (GLATO2017)
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ClinicalTrials.gov Identifier: NCT03063983 |
Recruitment Status : Unknown
Verified March 2017 by Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer.
Recruitment status was: Recruiting
First Posted : February 24, 2017
Last Update Posted : March 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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Osteosarcoma | Drug: Cyclophosphamide Drug: Methotrexate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 158 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 2, 2017 |
Estimated Primary Completion Date : | January 2, 2019 |
Estimated Study Completion Date : | January 31, 2022 |

Arm | Intervention/treatment |
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Experimental: Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
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Drug: Cyclophosphamide
Continuous oral cyclophosphamide Drug: Methotrexate Continuous oral methotrexate |
No Intervention: Control
31 weeks of MAP
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- Efficacy and toxicity of adding metronomic therapy in disease event-free survival. [ Time Frame: Five years ]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.
- Efficacy and toxicity of adding metronomic therapy in overall survival [ Time Frame: Five years ]To evaluate the impact of the addition of metronomic therapy to the standard treatment of patients with end-resectable osteosarcoma and metastatic lung disease in overall survival.
- Cardiotoxicity (occurrence of cardiotoxicity) [ Time Frame: Five years ]To compare the occurrence of cardiotoxicity with the addition of dexrazoxane since the first cycle of doxorubicin with the findings of the previous study (GLATO 2006).
- Immunohistochemistry (expression of VEGF) [ Time Frame: Five years ]Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases

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Ages Eligible for Study: | up to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063983
Contact: Antonio S Petrilli | +55 (11) 5080-8400 | sergiopetrilli@graacc.org.br | |
Contact: Andreza A Senerchia | +55 (11) 5080-8400 | andrezasenerchia@graacc.org.br |
Brazil | |
Grupo de Apoio ao Adolescente e a Criança com Câncer | Recruiting |
Sao Paulo, Brazil, 04039001 | |
Contact: Antonio S Petrilli +55 (11) 5080-8400 sergiopetrilli@graacc.org.br | |
Contact: Andreza A Senerchia +55 (11) 5080-8400 andrezasenerchia@graacc.org.br |
Study Chair: | Cláudia F Fontes | Grupo de Apoio ao Adolescente e a Crianca com Cancer |
Responsible Party: | Antônio Sérgio Petrilli, Principal Investigator, Grupo de Apoio ao Adolescente e a Crianca com Cancer |
ClinicalTrials.gov Identifier: | NCT03063983 |
Other Study ID Numbers: |
GLATO2017 |
First Posted: | February 24, 2017 Key Record Dates |
Last Update Posted: | March 13, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
osteosarcoma metastatic metronomic therapy |
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Cyclophosphamide Methotrexate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |