Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02273583
Status:
UNKNOWN
Last Update Posted:
2016-02-11
First Post:
2014-07-07
Brief Title:
Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade Operable Non-metastatic Osteosarcoma of the Extremity
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:
None
Status:
UNKNOWN
Status Verified Date:
2016-02
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:
None
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 non-metastatic osteosarcoma OST of the extremities The primary end point is event-free survival EFS from randomization
Detailed Description:
The study design includes a backbone of 10 weeks of preoperative therapy using MAP High-dose methotrexate cisplatin and doxorubicin Following surgery non-metastatic patients were randomized by blocks to complete 31 weeks of MAP or to receive 73 weeks of maintenance therapy following MAP while metastatic patients received maintenance therapy in combination with MAP since the beginning of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None