Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593899
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Total Neoadjuvant Therapy for Hypofractionated Radiotherapy Combined with AI Regimens in Soft Tissue Sarcoma of the Extremities a Phase 2 Single Arm Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For localized soft tissue sarcomas STS of the extremities limb-sparing or conservative surgery with perioperative radiotherapy RT is the standard of care However several challenges persist Notably there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT and conventional fractionated radiotherapy has a prolonged duration 5-6 weeks With advancements in RT technology the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations Promising recent reports on 1-week hypofractionated RT regimens such as the 5X5 Gy RT regimens have demonstrated reasonable local control and acceptable toxicity in resectable STSAddressing the challenge of distant metastasis previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse Therefore the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapyAI regimenscan enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities
Detailed Description:
None
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