Non-OpeRative MANagement of Rectal Cancer Patients

Rectal Cancer Clinical Trial

— NORMANDY  

Official title:

Non-OpeRative MANagement of Rectal Cancer Patients Who Had Clinical Complete Response After Pre-operative Chemo-raDiotherapY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696757
• Other study ID #: NORMANDY
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Kangbuk Samsung Hospital
• Contact: Dong-Hoe Koo
• Phone: +82-2001-8330
• Email: dhkoo.smc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• Clinical CR after pre-operative CRT for Rectal cancer

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Chemoradiotherapy
• Rectal Cancer
• Rectal Neoplasms
• Watch & Wait

Intervention

Drug:
• Capecitabine
Capecitabine without surgery

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	Disease-free survival	Duration from Pre-operative CRT