Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

Osteosarcoma Clinical Trial

— GLATO2017  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063983
• Other study ID #: GLATO2017
• 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
• 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.

Related Conditions & MeSH terms

• Osteosarcoma

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