Non-OpeRative MANagement of Rectal Cancer Patients
- Registration Number
- NCT04696757
- Lead Sponsor
- Kangbuk Samsung Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Clinical CR after pre-operative CRT for Rectal cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cape Capecitabine Capecitabine without surgery
- Primary Outcome Measures
Name Time Method DFS Duration from Pre-operative CRT Disease-free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of