Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03063983
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2017-01-27
Brief Title:
Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma
Sponsor:
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Organization:
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLATO2017
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None