Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450574
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-19
Brief Title:
Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0 M0 Rectal Cancer TAUTEM-T1 Study
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
Prospective Controlled and Randomized Phase III Multicentric Study of the Treatment of T1N0M0 Rectal Cancer Neoadjuvant Therapy and Transanal Endoscopic Surgery vs Transanal Endoscopic Surgery TAUTEM-T1 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
TAUTEM-T1
Brief Summary:
Introduction The standard treatment for rectal adenocarcinoma is total mesorectal excision TME a technique involving resection of the rectum with or without a temporary or permanent stoma TME is associated with high morbidity and genitourinary alterations On the other hand transanal endoscopic surgery TEM allows access to tumors up to 20 cm from the anal margin with much lower postoperative morbidity and without the need for ostomy For T1 N0 M0 rectal adenocarcinomas without poor prognostic factors TEM is the technique of choice However recent studies have described local recurrences of up to 20 Our group TAUTEM has just completed a phase III clinical trial in T2-T3ab N0 M0 rectal cancer comparing preoperative chemoradiotherapy CRT and TEM versus TME with very positive results in terms of postoperative morbidity quality of life and a local recurrence rate of 74 not inferior to TME
These results encourage our TAUTEM group to launch a similar project at the T1 N0 M0 stage comparing standard TEM treatment versus QRT and TEM aiming to improve rectal preservation outcomes and enhance results regarding local recurrence distant recurrence and oncologic survival
Method Prospective controlled randomized phase III multicenter clinical trial Patients with rectal adenocarcinoma within 10 cm of the anal margin and up to 4 cm in size staged as T1 N0 M0 will be included These patients will be randomized into two groups TEM after CRT and TEM alone Postoperative morbidity and mortality CRT side effects and quality of life will be recorded The minimum follow-up will evaluate rectal preservation and local recurrence and survival at two and three years The sample size calculation for the study will be 106 patients
Conclusions The aim of the study is to improve oncological outcomes in stage T1 N0 M0 rectal cancer through preoperative chemoradiotherapy associated with local surgery TEM
These results encourage our TAUTEM group to launch a similar project at the T1 N0 M0 stage comparing standard TEM treatment versus QRT and TEM aiming to improve rectal preservation outcomes and enhance results regarding local recurrence distant recurrence and oncologic survival
Method Prospective controlled randomized phase III multicenter clinical trial Patients with rectal adenocarcinoma within 10 cm of the anal margin and up to 4 cm in size staged as T1 N0 M0 will be included These patients will be randomized into two groups TEM after CRT and TEM alone Postoperative morbidity and mortality CRT side effects and quality of life will be recorded The minimum follow-up will evaluate rectal preservation and local recurrence and survival at two and three years The sample size calculation for the study will be 106 patients
Conclusions The aim of the study is to improve oncological outcomes in stage T1 N0 M0 rectal cancer through preoperative chemoradiotherapy associated with local surgery TEM
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