Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462053
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Prospective Randomized Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
TORCH-E2
Brief Summary:
TORCH-E2 is a prospective multicentre randomized phase II trial 134 low-lying early T1-3bN0-1M0 distance from anal verge 5cm patients will be recruited and assigned to Group 1 and Group 2 11 Group 1 receives SCRT 25Gy5Fx followed by 4 cycles of capecitabine plus oxaliplatin CAPOX chemotherapy and PD-1 antibody Group 2 receives LCRT 50Gy25Fx followed by 2 cycles of CAPOX A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR 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 AE rate anal preservation rate 3-year DFS rate etc
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