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Non-OpeRative MANagement of Rectal Cancer Patients (NORMANDY)

Primary Purpose

Rectal Cancer, Chemoradiotherapy, Watch & Wait

Status

Recruiting

Phase

Early Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Capecitabine

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Chemoradiotherapy, Watch & wait, Capecitabine

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical CR after pre-operative CRT for Rectal cancer

Exclusion Criteria:

Sites / Locations

Kangbuk Samsung HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cape

Arm Description

Capecitabine without surgery

Outcomes

Primary Outcome Measures

DFS

Disease-free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT04696757

First Posted

January 4, 2021

Last Updated

March 7, 2023

Sponsor

Kangbuk Samsung Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04696757

Brief Title

Non-OpeRative MANagement of Rectal Cancer Patients

Acronym

NORMANDY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kangbuk Samsung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer, Chemoradiotherapy, Watch & Wait

Keywords

Rectal Cancer, Chemoradiotherapy, Watch & wait, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cape

Arm Type

Experimental

Arm Description

Capecitabine without surgery

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Capecitabine without surgery

Primary Outcome Measure Information:

Title

DFS

Description

Disease-free survival

Time Frame

Duration from Pre-operative CRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical CR after pre-operative CRT for Rectal cancer Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong-Hoe Koo

Phone

+82-2001-8330

dhkoo.smc@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong-Hoe Koo

Organizational Affiliation

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kangbuk Samsung Hospital

City

Seoul

ZIP/Postal Code

110-746

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong-Hoe Koo, MD,PhD

Phone

+82-2-2001-8330

d.h.koo@samsung.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Non-OpeRative MANagement of Rectal Cancer Patients

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