Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04656262
Status:
TERMINATED
Last Update Posted:
2024-07-08
First Post:
2020-11-25
Brief Title:
Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized Controlled Open Label Clinical Trial
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
enrollment too slow to reach the target in a reasonable time frame
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METROPHOLYS
Brief Summary:
To compare the efficacy as measured by time to treatment failure of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS
Detailed Description:
This phase III randomized clinical trial was designed to compare metronomic Cyclophosphamide with standard Doxorubicin for the first-line treatment of elderly cancer patients with advanced inoperable or metastatic STS
i ARM A experimental Metronomic Cyclophosphamide ii ARM B control Doxorubicin up to six cycles
i ARM A experimental Metronomic Cyclophosphamide ii ARM B control Doxorubicin up to six cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None