Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868317
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-22
First Post:
2023-04-14
Brief Title:
Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer
Sponsor:
Salah Azaïz Cancer Institute
Organization:
Salah Azaïz Cancer Institute
Study Overview
Official Title:
Induction Chemotherapy With FOLFIRINOX 5 Fluorouracil Oxaliplatine and Irinotecan Followed by Short Course Radiotherapy in Locally Advanced Rectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy RT in locally advanced rectal carcinoma
Detailed Description:
Total neoadjuvant treatment TNT is currently the standard of care in the management of locally advanced rectal cancer since recent studies have shown improved pathological complete response and disease-free survival with this approach However survival benefits remain unproven
Two strategies of TNT are validated so far induction chemotherapy with FOLFIRINOX followed by long course radio-chemotherapy RCT or short course RT 5x5 Gy followed by consolidation chemotherapy with CAPOX capecitabine and oxaliplatin or FOLFOX 5 FU and oxaliplatin
The objective of investigators is to evaluate pathological complete response with a new strategy of TNT consisting in induction chemotherapy with FOLFIRINOXm followed by short course RT and a delayed surgery
Two strategies of TNT are validated so far induction chemotherapy with FOLFIRINOX followed by long course radio-chemotherapy RCT or short course RT 5x5 Gy followed by consolidation chemotherapy with CAPOX capecitabine and oxaliplatin or FOLFOX 5 FU and oxaliplatin
The objective of investigators is to evaluate pathological complete response with a new strategy of TNT consisting in induction chemotherapy with FOLFIRINOXm followed by short course RT and a delayed surgery
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?:
False
Is an FDA AA801 Violation?:
None