Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142571
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
2005-08-31
Brief Title:
Comparison of Gemcitabine v Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Ph III Random Trial of 120-Min Infusion Gemcitabine v 90-Min Infusion Gemcitabine Docetaxel in Unresectable Soft Tissue Sarcoma A Multi-Disciplinary Trial of the North Amer Sarcoma Study Group of the Connective Tissue Oncology Society
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
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:
The purpose of this study is to compare the drug gemcitabine to two drugs gemcitabine and docetaxel to find out which treatment is better for people with sarcomas
Detailed Description:
This research is being done because better treatments for sarcomas are needed This is a phase III study This means that one treatment is being compared to another to find out which is better We are comparing the drug gemcitabine to the two drugs gemcitabine and docetaxel to find out which treatment is better for people who have sarcomas From previous studies we know that gemcitabine causes shrinking of some peoples sarcoma tumors We also know that gemcitabine and docetaxel are useful for sarcomas as well but we believe the two drugs together may be more toxic than the single drug alone In this study we are trying to answer the question Is the combination of gemcitabine and docetaxel any better than just gemcitabine alone
This is a randomized Phase III trial comparing two treatment regimens in patients with unresectable soft tissue sarcoma The failure rates observed on both treatment arms failure defined as progression or death will be compared to determine which regimen results in the lowest failure rate Primary objective As a secondary endpoint the percentage of patients who are failure-free failure defined as progression or death at 3 months and 6 months will be compared between the two arms Secondary objective
This trial sponsored by the North American Sarcoma Study Group of the Connective Tissue Oncology Society is being done at a number of hospitals around the country and is expected to enroll up to 120 patients
This is a randomized Phase III trial comparing two treatment regimens in patients with unresectable soft tissue sarcoma The failure rates observed on both treatment arms failure defined as progression or death will be compared to determine which regimen results in the lowest failure rate Primary objective As a secondary endpoint the percentage of patients who are failure-free failure defined as progression or death at 3 months and 6 months will be compared between the two arms Secondary objective
This trial sponsored by the North American Sarcoma Study Group of the Connective Tissue Oncology Society is being done at a number of hospitals around the country and is expected to enroll up to 120 patients
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