Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864067
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2021-04-25
Brief Title:
No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
Sponsor:
Servicio de Salud Metropolitano Sur Oriente
Organization:
Servicio de Salud Metropolitano Sur Oriente
Study Overview
Official Title:
No Operation After Short Course Equivalent Dose Ht Radiation Therapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer The Prospective Single Arm NOAHS-ARC Trial
Status:
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:
NOAHS-ARC
Brief Summary:
This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer LARC treated with a Total neoadjuvant therapy TNT strategy based on short course radiotherapy 5x5Gy followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained 1year complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy CRT total mesorectal excision TME and adjuvant chemotherapy ACT
Detailed Description:
Non-operative management with a Watch and Wait WW strategy has been advocated for selected patients with a locally advanced rectal cancer LARC and a complete clinical response cCR after neoajuvant NA treatment
In this context total neoadjuvant therapy TNT ie the use of radiotherapy and full dose of post-operative chemotherapy as part of NA treatment has emerged as a strategy to enhance treatment response
Currently TNT has reported higher rates of pCR and organ preservation when compared to current standard of care However the best TNT strategy is still unknown We therefore hypothesize that in LARC patients the use of a TNT strategy based on short course RT followed by consolidation chemotherapy is associated with a higher rate of pCR and sustained 1year cCR when compared to an historic cohort
The main aim of the present proposal is to assess the effects of a standardized TNT model in LARC patients as a strategy for enhanced pCRsustained cCR For this purpose we propose the following experimental model In primary Aim 1 we will study if the effects of a TNT strategy over patients with a LARC enhance the rate of pCRsustained cCR by 1 evaluating the compliance and toxicity of a TNT strategy as a proof of concept of its applicability 2 assessing the rate of cCR at the end of TNT and 3 assessing the rate of pCR in the surgically managed subgroup and sustained cCR 1year in the WW subgroup Additionally in primary Aim 2 we will determine if patients with a WW strategy have better functional outcomes and quality of life QoL than patients treated with TME after TNT by 1 using validated questionnaires for the evaluation of bowel sexual and urinary function for WW and TME patients and 2 by evaluating the QoL using a widely-used standardized questionnaire
In this context total neoadjuvant therapy TNT ie the use of radiotherapy and full dose of post-operative chemotherapy as part of NA treatment has emerged as a strategy to enhance treatment response
Currently TNT has reported higher rates of pCR and organ preservation when compared to current standard of care However the best TNT strategy is still unknown We therefore hypothesize that in LARC patients the use of a TNT strategy based on short course RT followed by consolidation chemotherapy is associated with a higher rate of pCR and sustained 1year cCR when compared to an historic cohort
The main aim of the present proposal is to assess the effects of a standardized TNT model in LARC patients as a strategy for enhanced pCRsustained cCR For this purpose we propose the following experimental model In primary Aim 1 we will study if the effects of a TNT strategy over patients with a LARC enhance the rate of pCRsustained cCR by 1 evaluating the compliance and toxicity of a TNT strategy as a proof of concept of its applicability 2 assessing the rate of cCR at the end of TNT and 3 assessing the rate of pCR in the surgically managed subgroup and sustained cCR 1year in the WW subgroup Additionally in primary Aim 2 we will determine if patients with a WW strategy have better functional outcomes and quality of life QoL than patients treated with TME after TNT by 1 using validated questionnaires for the evaluation of bowel sexual and urinary function for WW and TME patients and 2 by evaluating the QoL using a widely-used standardized questionnaire
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