Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 5:40 PM
Study NCT ID:
NCT04696757
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2021-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-OpeRative MANagement of Rectal Cancer Patients
Sponsor:
Kangbuk Samsung Hospital
Organization:
Study Overview
Official Title:
Non-OpeRative MANagement of Rectal Cancer Patients Who Had Clinical Complete Response After Pre-operative Chemo-raDiotherapY
Status:
COMPLETED
Status Verified Date:
2025-02
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:
NORMANDY
Brief Summary:
This study is a single-center, open, prospective, single-treatment trial (pilot study). This study aims to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer and to investigate the feasibility of non-surgical treatment.
Detailed Description:
Indication:
1. mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination,
2. the tumor was located at the lower boundary of the tumor spans the anorectal junction, and the clinical stage is stage 2 or 3, and
3. clinical complete remission was confirmed after the treatment response evaluation at 8 weeks after completion of preoperative chemoradiotherapy according to MR/SFS and biopsy.
Aim:
1. to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer
2. to investigate the feasibility of non-surgical treatment.
1. mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination,
2. the tumor was located at the lower boundary of the tumor spans the anorectal junction, and the clinical stage is stage 2 or 3, and
3. clinical complete remission was confirmed after the treatment response evaluation at 8 weeks after completion of preoperative chemoradiotherapy according to MR/SFS and biopsy.
Aim:
1. to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer
2. to investigate the feasibility of non-surgical treatment.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: