Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04037527
Status:
TERMINATED
Last Update Posted:
2025-12-17
First Post:
2019-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities
Status:
TERMINATED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low accruals
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 Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.
Detailed Description:
Primary Objective:
• To determine the maximum tolerated doses Gemcitabine and Taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities.
Secondary Objective:
• To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. This would include T cell subsets, NK, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment.
Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.
• To determine the maximum tolerated doses Gemcitabine and Taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities.
Secondary Objective:
• To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. This would include T cell subsets, NK, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment.
Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |
| CCCWFU 71117 | OTHER | Wake Forest Baptist Comprehensive Cancer Center | View |