NCT04696757

Non-OpeRative MANagement of Rectal Cancer Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Chemoradiotherapy
• Watch & Wait

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine without surgery

Timeline

• Start date: 2018-02-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-01-06
• Last updated: 2025-02-12

Locations

1 site across 1 country: South Korea