Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-09
Brief Title:
Total Neoadjuvant Therapy for Adenocarcinoma of the OESophagus and Oesophagogastric Junction TNT-OES-2 Trial
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Total Neoadjuvant Therapy for Adenocarcinoma of the OESophagus and Oesophagogastric Junction TNT-OES-2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
TNT-OES-2
Brief Summary:
Both neoadjuvant chemoradiotherapy CROSS and neoadjuvant chemotherapy FLOT have demonstrated overall survival benefit over surgery alone in esophageal and esophagogastric junction EGJ cancer Despite these survival gains the prognosis remains poor especially in patients with nodal-positive adenocarcinoma cN AC 5-year survival 36 compared to 55 for cN0 This highlights the need for more effective treatment options and justifies treatment intensification in these patients
The aim of this study is to determine the efficacy and feasibility of TNT FLOT-CROSS and TNT CROSS-FLOT in patients with resectable cN AC of the esophagus or EGJ
The aim of this study is to determine the efficacy and feasibility of TNT FLOT-CROSS and TNT CROSS-FLOT in patients with resectable cN AC of the esophagus or EGJ
Detailed Description:
This study hypothesize that the benefits of the locoregional control of CROSS combined with the systemic effect of FLOT lead to better disease control and survival in cN AC patients This Total Neoadjuvant Treatment TNT strategy was found to be feasible in the previous TNT-OES-1 trial The optimal sequence of CROSS and FLOT is yet unknown Therefore the hypothesis of this study is that the disease-free survival DFS of patients treated with TNT FLOT-CROSS and TNT CROSS-FLOT will be 10 compared to the DFS after CROSS in an appropriate historical cohort
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