Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06097416
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-18
Brief Title:
Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer
Sponsor:
St Jamess Hospital Ireland
Organization:
St Jamess Hospital Ireland
Study Overview
Official Title:
A Phase III Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy NARCT and Total Neoadjuvant Therapy TNT in Patients With T3 abc Rectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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 gold standard treatment for locally advanced non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy NACRT total mesorectal excision TME and adjuvant chemotherapy AC The primary goal of treatment is to achieve local disease control reduce tumour volume and minimise the risk of distant metastases While this multimodal treatment approach has offered improvements in local control and sphincter preservation it has had little effect on distant recurrence and overall survival We aim to compare NACRT and TME using the following endpoints
Primary --To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy TNT for T3 rectal cancer on overall survival
Secondary -- To compare the effects neoadjuvant chemoradiotherapy NARCT and total neoadjuvant therapy TNT for cT3 rectal cancer on clinical outcomes
Clinical complete response cCR
Pathological complete response pCR
Disease-free survival DFS
Organ preservation
Overall morbidity mortality
Treatment-related morbidity mortality
Peri-operative outcomes
Primary --To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy TNT for T3 rectal cancer on overall survival
Secondary -- To compare the effects neoadjuvant chemoradiotherapy NARCT and total neoadjuvant therapy TNT for cT3 rectal cancer on clinical outcomes
Clinical complete response cCR
Pathological complete response pCR
Disease-free survival DFS
Organ preservation
Overall morbidity mortality
Treatment-related morbidity mortality
Peri-operative outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None