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

Summary

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

• Rectal Cancer
• Rectal Adenocarcinoma

Interventions

PROCEDURE

Nonoperative surveillance

Clinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT

Sponsors & Collaborators

• Tampere University

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Jyväskylä Central Hospital

  collaborator OTHER

• Seinajoki Central Hospital

  collaborator OTHER

• Satakunta Central Hospital

  collaborator OTHER

• North Karelia Central Hospital

  collaborator OTHER

• Tartu University Hospital

  collaborator OTHER

• East Tallinn Central Hospital

  collaborator OTHER

• West Tallinn Central Hospital

  collaborator UNKNOWN

• North Estonia Medical Centre

  collaborator OTHER

• Vaasa Central Hospital, Vaasa, Finland

  collaborator OTHER

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Toni T Seppälä, MD, PhD · Tampere University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-16

Primary Completion

2028-12-31

Completion

2032-12-31

Countries

• Estonia
• Finland

Study Locations