Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301165
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-24
Brief Title:
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma a Multi-center Phase II Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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 NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma NPC However meta-analyses have shown significant survival differences between different induction chemotherapy regimens How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs with high penetration and long retention effects which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue It remains to be investigated whether the TPC paclitaxel cisplatin and capecitabine regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP gemcitabine cisplatin regimen can further improve therapeutic effects in high-risk patients with locally advanced disease There is still a lack of head-to-head studies for comparison This study aims to compare through a prospective parallel-controlled randomized open-label multicenter phase II clinical trial the TPC induction chemotherapy vs the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC T4 or N2-3 in terms of 2-year progression-free survival overall survival overall response rate toxic side effects etc
Detailed Description:
None
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