Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06328361

Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Led by Tampere University Hospital · Updated on 2025-09-02

200

Participants Needed

13

Research Sites

450 weeks

Total Duration

On this page

Sponsors

T

Tampere University Hospital

Lead Sponsor

T

Tampere University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate

CONDITIONS

Official Title

Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathological verification of primary rectal adenocarcinoma
  • Complete clinical response at response assessment after neoadjuvant therapy
  • Informed consent to organ preservation study
Not Eligible

You will not qualify if you...

  • Evidence of metastatic disease (fulfilling M-class criteria of TNM)
  • No neoadjuvant therapy
  • Inability to understand the information related to harms and benefits

AI-Screening

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Trial Site Locations

Total: 13 locations

1

East Tallinn Central Hospital

Tallinn, Estonia

Actively Recruiting

2

North Estonia Medical Centre

Tallinn, Estonia

Actively Recruiting

3

West Tallinn Central Hospital

Tallinn, Estonia

Actively Recruiting

4

Tartu University Hospital

Tartu, Estonia

Actively Recruiting

5

Helsinki University Central Hospital

Helsinki, Finland, 00290

Actively Recruiting

6

Jyväskylä Central Hospital

Jyväskylä, Finland

Actively Recruiting

7

Kuopio University Hospital

Kuopio, Finland

Actively Recruiting

8

Oulu University Hospital

Oulu, Finland

Actively Recruiting

9

Satakunta Central Hospital

Pori, Finland

Actively Recruiting

10

Seinajoki Central Hospital

Seinäjoki, Finland

Actively Recruiting

11

Tampere University Hospital

Tampere, Finland, 33400

Actively Recruiting

12

Turku University Hospital

Turku, Finland

Actively Recruiting

13

Vaasa Central Hospital

Vaasa, Finland, 65100

Not Yet Recruiting

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Research Team

T

Toni T Seppälä, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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