Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma (GLATO2017)

March 9, 2017 updated by: Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
Drug: Cyclophosphamide
Continuous oral cyclophosphamide
Drug: Methotrexate
Continuous oral methotrexate
NO_INTERVENTION: Control
31 weeks of MAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five years
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).
Five years
Immunohistochemistry (expression of VEGF)
Time Frame: Five years
Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Apoio ao Adolescente e a Crianca com Cancer

Investigators

  • Study Chair: Cláudia F Fontes, Grupo de Apoio ao Adolescente e à Criança com Câncer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2017

Primary Completion (ANTICIPATED)

January 2, 2019

Study Completion (ANTICIPATED)

January 31, 2022

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (ACTUAL)

February 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLATO2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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