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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03063983
Other study ID # GLATO2017
Secondary ID
Status Recruiting
Phase Phase 2
First received January 27, 2017
Last updated March 9, 2017
Start date January 2, 2017
Est. completion date January 31, 2022

Study information

Verified date March 2017
Source Grupo de Apoio ao Adolescente e a Crianca com Cancer
Contact Antonio S Petrilli
Phone +55 (11) 5080-8400
Email sergiopetrilli@graacc.org.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The study design includes backbone of 10 weeks of preoperative therapy using MAP (high-dose methotrexate, cisplatin, doxorubicin and dexrazoxane). Metastatic patients were randomized to high-dose chemotherapy for 31 weeks (arm 1) or concomitant metronomic therapy (MTX plus cyclophosphamide) such as 31 weeks of high-dose chemotherapy, followed by 73 weeks of metronomic therapy after completion of high-dose chemotherapy, totaling 104 weeks of metronomic therapy (arm 2).


Recruitment information / eligibility

Status Recruiting
Enrollment 158
Est. completion date January 31, 2022
Est. primary completion date January 2, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 30 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide
Continuous oral cyclophosphamide
Methotrexate
Continuous oral methotrexate

Locations

Country Name City State
Brazil Grupo de Apoio ao Adolescente e a Criança com Câncer Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Grupo de Apoio ao Adolescente e a Crianca com Cancer

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy and toxicity of adding metronomic therapy in disease event-free survival. 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. Five years
Secondary Efficacy and toxicity of adding metronomic therapy in overall survival 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. Five years
Secondary Cardiotoxicity (occurrence of cardiotoxicity) 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). Five years
Secondary Immunohistochemistry (expression of VEGF) Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases Five years
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