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

Primary Purpose

Osteosarcoma

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cyclophosphamide
Methotrexate
Sponsored by
Grupo de Apoio ao Adolescente e a Crianca com Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring osteosarcoma, metastatic, metronomic therapy

Eligibility Criteria

1 Day - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grupo de Apoio ao Adolescente e a Criança com CâncerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Maintenance therapy

Control

Arm Description

104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP

31 weeks of MAP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Immunohistochemistry (expression of VEGF)
Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases

Full Information

First Posted
January 27, 2017
Last Updated
March 9, 2017
Sponsor
Grupo de Apoio ao Adolescente e a Crianca com Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT03063983
Brief Title
Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
January 2, 2019 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo de Apoio ao Adolescente e a Crianca com Cancer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
osteosarcoma, metastatic, metronomic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maintenance therapy
Arm Type
Experimental
Arm Description
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
Arm Title
Control
Arm Type
No Intervention
Arm Description
31 weeks of MAP
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Continuous oral cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Continuous oral methotrexate
Primary Outcome Measure Information:
Title
Efficacy and toxicity of adding metronomic therapy in disease event-free survival.
Description
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.
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Efficacy and toxicity of adding metronomic therapy in overall survival
Description
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.
Time Frame
Five years
Title
Cardiotoxicity (occurrence of cardiotoxicity)
Description
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).
Time Frame
Five years
Title
Immunohistochemistry (expression of VEGF)
Description
Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio S Petrilli
Phone
+55 (11) 5080-8400
Email
sergiopetrilli@graacc.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Andreza A Senerchia
Phone
+55 (11) 5080-8400
Email
andrezasenerchia@graacc.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cláudia F Fontes
Organizational Affiliation
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Official's Role
Study Chair
Facility Information:
Facility Name
Grupo de Apoio ao Adolescente e a Criança com Câncer
City
Sao Paulo
ZIP/Postal Code
04039001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio S Petrilli
Phone
+55 (11) 5080-8400
Email
sergiopetrilli@graacc.org.br
First Name & Middle Initial & Last Name & Degree
Andreza A Senerchia
Phone
+55 (11) 5080-8400
Email
andrezasenerchia@graacc.org.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

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