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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04696757

Acronym

NORMANDY

Enrollment

Registered

2021-01-06

Start date

2018-02-01

Completion date

2024-12-31

Last updated

2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemoradiotherapy, Rectal Cancer, Watch & Wait

Keywords

Rectal Cancer, Chemoradiotherapy, Watch & wait, Capecitabine

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.

Interventions

DRUGCapecitabine

Capecitabine without surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Clinical CR after pre-operative CRT for Rectal cancer

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
DFS	Duration from Pre-operative CRT	Disease-free survival

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026