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NCT Number: NCT04696757

Non-OpeRative MANagement of Rectal Cancer Patients

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.

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Key information

Conditions

Rectal Cancer Chemoradiotherapy Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Watch & Wait

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

About this study

Indication:

  • mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination,
  • 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
  • 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:

  • 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
  • to investigate the feasibility of non-surgical treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical CR after pre-operative CRT for Rectal cancer

Exclusion criteria

-

Treatment and study plan

Capecitabine

Drug

Capecitabine without surgery

Primary outcomes

  1. DFS

    Time frame: Duration from Pre-operative CRT

    Disease-free survival

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Acronym: NORMANDY

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2021
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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