Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652412
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients With Inoperable Localized CRC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Geriatric Assessment CGA Guided Ultrafractionated Radiotherapy and Systemic Treatment in Elderly or Frail Patients With Inoperable Localized Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicentre cohort study For cohort 1 experimental cohort older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy RT and Comprehensive Geriatric Assessment CGA Guided systemic treatment All patients will receive Ultrafractionated RT and PD-1 antibody Furthermore CGA will assess all patients and classify them into Frail Vulnerabe or Fit Frail patients will receive Best Supportive Care BSC Vulnerabe patients will receive FluorouracilRaltitrexed and BSC Fit patients will receive FluorouracilRaltitrexed OxaliplatinIrinotecan and BSC
For cohort 2 external control from real word data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected
The primary endpoint is complete response CR pathological complete response pCR plus cCR rate The secondary endpoints include the grade 3-4 acute adverse effects rate anal preservation rate survival etc
For cohort 2 external control from real word data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected
The primary endpoint is complete response CR pathological complete response pCR plus cCR rate The secondary endpoints include the grade 3-4 acute adverse effects rate anal preservation rate survival etc
Detailed Description:
This is a prospective multicentre cohort study For cohort 1 experimental cohort older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy RT and Comprehensive Geriatric Assessment CGA Guided systemic treatment All patients will receive Ultrafractionated RT and PD-1 antibody Furthermore CGA will assess all patients and classify them into Frail Vulnerabe or Fit Frail patients will receive Best Supportive Care BSC Vulnerabe patients will receive FluorouracilRaltitrexed and BSC Fit patients will receive FluorouracilRaltitrexed OxaliplatinIrinotecan and BSC
For cohort 2 external control from real word data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected
The primary endpoint is complete response CR pathological complete response pCR plus cCR rate The secondary endpoints include the grade 3-4 acute adverse effects rate anal preservation rate 1-year DFS rate 1-year DSS rate 1-year OS rate etc
For cohort 2 external control from real word data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected
The primary endpoint is complete response CR pathological complete response pCR plus cCR rate The secondary endpoints include the grade 3-4 acute adverse effects rate anal preservation rate 1-year DFS rate 1-year DSS rate 1-year OS rate etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None